Lord Rooker: My Lords, I understand why my noble friend asks his supplementary, but there is no way under the present financial regime, or under the previous one, that there would have been £55 billion of investment in the less than 20 years since privatisation. I agree with what he says about Thames Water: it is the worst offender, losing through leakage something like 890 tonnes of water a day—I think that that should be million of tonnes a day. It has a massively high leakage level. It has no excuse based on money, as its profits have been more than sufficient for it to carry out the infrastructure works. And, indeed, it is doing that throughout London. At the moment, parts of London are absolutely clogged and half the road has disappeared because Thames Water is replacing the Victorians' legacy, on which we have dined out for too long.

Lord Goodhart: asked Her Majesty's Government:
	Whether they will transfer responsibility for criminal justice from the Home Office to the Department for Constitutional Affairs, so as to create a Department for Justice.

Baroness Scotland of Asthal: My Lords, the noble Lord will know that that is not what my right honourable friend the Home Secretary said about the Home Office. He said that one part—the processes related to IND—was not fit for purpose, but it does not apply to the Home Office as a whole. I am sure that the noble Lord knows that perfectly well.

Baroness Scotland of Asthal: My Lords, we certainly do not feel that that is necessary. The noble and learned Lord will know that the prosecution department is currently brilliantly headed by my noble and learned friend the Attorney-General. It is a situation with which we are absolutely content. Working together in unison, however, has been greatly beneficial, and we intend to continue along that line.

Lord Jenkin of Roding: My Lords, I do not think we should agree to this Motion without further discussion. Given the history of the Bill, which was massively amended in another place, and the raft of amendments which the Government have tabled to the Bill as introduced into this House, I do not think we should accept this Motion without once again asking whether we really need this Bill.
	The question was asked several times at Second Reading on 13 June, but—and I say this in all kindness—in his winding-up speech the Minister failed to convince many of your Lordships of the case he was seeking to make. For instance, the noble Lord, Lord Garden, asked,
	"why can current legislation not be used?—[Official Report, 13/6/06; col. 187.]
	When the Minister came to answer that question, the first thing he stressed—and I think it is important to notice what he gave the most importance to—was that it would help,
	"to create a regulatory environment—the culture to which the noble Lord, Lord Kingsland, referred".—[Official Report, 13/6/06; col. 188.]
	My noble friend, of course, was referring to the culture in Whitehall departments, which the Minister acknowledged seemed to be reluctant to engage in deregulation. But if departments are unwilling to deregulate—if the culture does indeed need to be changed—surely to goodness it is the job of the Ministers who head the departments to make sure that change is achieved.
	What is there in this Bill that is supposed, miraculously, to convert officials to embrace the spirit of deregulation? Yes, it provides some new definitions, for example, of the burdens that can be removed or reduced by order. So one goes on to ask, as several noble Lords did on Second Reading, including the noble Lord, Lord Goodhart, why cannot the 2001 Act be amended,
	"to make it a little less complex and technical?"—[Official Report, 13/6/06; col. 189.]
	The noble Lord got no answer either, except that the Minister riposted by inviting him to use the Committee stage to "have a go", as he put it, at drafting amendments that simplified things. It may be that the noble Lord's amendments, of which there are many, would do that.
	We now have this raft of new amendments, tabled by the Government in this House. For instance, Clause 3 contains the power to implement Law Commission reports by order, to which the noble Lord, Lord Bassam of Brighton, said at col. 186, he remained "wedded". He remained wedded in the letter he wrote to us, which I shall refer to in a moment. But we now see, looking at the Marshalled List, that Clause 3 is to be removed.
	The criteria written into the Bill to govern the use of the veto by committees of either House are to be removed. These are changes which I am sure the House will welcome, but why were those criteria in the Bill in the first place? Is this not evidence, if evidence were needed, that the Government are simply making up this Bill as they go along?
	When this Bill started its life in another place, it contained powers to legislate by order that were so sweeping and all-embracing that it attracted the sobriquet the "Abolition of Parliament" Bill. Mercifully, most of those powers were withdrawn in that House, so it was a radically different and far more modest measure that came to this House. But here we go again: the Marshalled List contains upward of 30 government amendments and proposals for the removal of two entire clauses. The noble Lord, Lord Bassam, was kind enough to send a number of us a letter which covered the points that had been raised at Second Reading. It is no fewer than nine foolscap pages long, plus an annex—let me say at once that I make no criticism of that: anything the Government can do to explain what they are trying to achieve must be an advantage. However, in the letter, the Minister once again tried to spell out why we needed the Bill rather than a much shorter measure amending the 2001 Act. He argued that the differences between the order-making powers in the Bill and in the 2001 Act,
	"are sufficiently significant to merit more than mere amendment of the 2001 Act".
	But I am driven to ask, if the Government had not originally attempted to introduce their far more drastic order-making power and to legislate by what was called the "Abolition of Parliament Act", whether they would not then have preferred to make the amendments in the form of a much shorter, simpler Bill, amending the 2001 Act. Would that not, even now, be a better course?
	Here we are, into July, with a very heavy legislative programme before us. Would it really not be wiser to recognise that this Bill, which in its present form still needs further to be amended, as witness the number of amendments on the Marshalled List, should be withdrawn before we waste any more time on it? Ministers could then really work out what they want to achieve and come back to the House in October with a simple amending Bill. I would hazard a guess that this might gain parliamentary approval quite quickly. Most of us are agreed on what needs to be done to speed up the process of deregulation. That would be a very much better way of doing it than starting to wade through this Committee now.

Lord Bassam of Brighton: My Lords, I join the noble Lord, Lord Richard, in being rather puzzled by this debate, although I thank the noble Lord, Lord Jenkin, for at least giving me advance notice of it.
	At Second Reading, we went carefully over the issue as to why a new Bill was required. I answered the points made and did so again, I thought fully, in the letter to which the noble Lord, Lord Jenkin, referred. We need a new Bill. Each Bill builds on another. This is hardly new territory, because noble Lords opposite will recall that they were the progenitors of a Bill back in 1994 that began this process.
	The noble Lord, Lord Jenkin, pointed out that we were bringing forward further sweeping changes, particularly in Clause 3, to which the noble Lord, Lord Kingsland, has also referred. Those changes were called for in considerable measure during the Second Reading debate. I listened to it. My noble friend Lady Ashton listened to it, as did my noble and learned friend the Lord Chancellor. We have reflected further on those issues and we have brought forward amendments to which I expect to receive welcome support from the Benches opposite.
	This Bill demonstrates that the Government are prepared to listen to those who criticise them and to bring forward thoughtful and sensible measures. Noble Lords opposite really need to understand and to get their act together, because on 14 April, I think, the Conservative Party produced a press release, which I do not have to hand, crediting the Government for making major amendments to the Bill and giving its support for that. I know that the Bill is supported by business. The CBI and the Institute of Directors have written to us. Today, I received a letter from the—

Lord Forsyth of Drumlean: I do not wish to detain the Committee for too long or go over old ground, but this amendment, which I support, is important. It makes a distinction between arbitrary use of power by a Minister and clear criteria. I do not know why I am not on the Minister's Christmas card list; I did not get a copy of his letter. Perhaps he sent it to me, but I have not seen a copy until this afternoon, when my noble friend Lord Jenkin kindly gave me his.
	I do not know if I am being thick but, moments ago, I asked the Minister whether he could give some examples of deregulatory measures which could not be dealt with under the 2001 Act. In the appendix to the Minister's letter there is indeed a reference to tree preservation orders and the amount of letter writing and bureaucracy involved in getting them. At Second Reading, the Minister made the point about game dealers. For the life of me, I still cannot understand why these measures could not be dealt with under the 2001 Act. The appendix sets out particular difficulties in the criteria and drafting of the 2001 Act, which could be dealt with by simple amendment.
	The amendment of the noble Lord, Lord Goodhart, is therefore important. I am concerned that this Bill gives Ministers powers for which they are not accountable to Parliament. When one sees woolly phrasing such as this, it means either something or nothing. If it means nothing, let us take it out. I would be grateful if the Minister could help me with this when he replies.
	My friends in the CBI come up to me and say "British business has an enormous regulatory burden which must be got rid of"; they do not say "We are particularly concerned about the tree preservation orders and gaming". From what the Minister says in his letters, both these points could be dealt with by simple amendment to the existing legislation, even if there is a problem. Given that these are the only examples he can come up with which cannot be dealt with under existing legislation, I find this worrying.
	Returning to the arguments that the Minister sets out in his letter—which should be widely available—he seems to suggest that the real problem is that Whitehall finds dealing with the 2001 Act rather a burden. At one point, he suggests that civil servants in Whitehall find it almost as difficult to deal with the 2001 Act as to introduce a Bill. Perhaps I have not been modernised and am a bit old-fashioned, but I think it should be extremely hard to change the law. People should have absolute clarity over what the law is. I support this amendment, and if the Minister is inclined to resist it, my concern about what is the underlying motivation for continuing with this legislation will increase.

Lord Bassam of Brighton: I shall deal with the two amendments of the noble Lord, Lord Goodhart, and with Amendments Nos. 27 and 39, which he, in friendly terms, grouped with them. I will deal with those in turn.
	For an order to be laid under Clause 1, the Minister must consider that it serves the purpose outlined in Clause 1(2) and satisfies the preconditions in Clause 4(2). Our view is that these are real tests. That is because the Minister is under a public law duty to be reasonable when forming a view on whether the order is within the terms of the order-making power in Clause 1 and meets the preconditions in Clause 4(2).
	The duty for a Minister to be reasonable connotes an obligation not to take into account irrelevant considerations and act for improper purposes or in bad faith. It also requires—and perhaps this is the most important element—the Minister to reach a rational decision.
	In the correspondence, which has been referred to on several occasions, I quoted the case law. I have no intention of going over that again, but it makes the point. The case law shows that the existing subjective tests in the Bill are real ones. Furthermore, the ministerial opinion requirement in the Bill is not new. It has worked well under the 2001 Act and, before that, the 1994 Act. There is absolutely no evidence, therefore, that this should be changed under this Bill.
	The Minister's opinion that he considers an order would serve the purpose in Clause 1 and the preconditions in Clause 4 is subject, as we have argued before, to stringent parliamentary scrutiny. The relevant committees of either House can veto any order if they do not consider it appropriate, and, unless the committee's veto is overturned by resolution of its House, all further proceedings of the order will be halted. The two Houses have equal status regarding the scrutiny of orders. A veto in either House would mean that proceedings are halted and the Minister would be required to withdraw the order.
	The Delegated Powers and Regulatory Reform Committee writes in its report:
	"When either House or a Committee considers a proposal, they can form their own judgment of the Minister's assessment as to whether the preconditions have been met and can disagree, if necessary reporting against the proposal".
	The Government agree with the Delegated Powers and Regulatory Reform Committee's report that the reference to ministerial opinion does not in any way weaken the requirement for the Minister's opinion to be reasonable and subject to rigorous challenge; it simply ensures that the detailed challenges and decisions—over, for example, what constitutes a necessary protection in a particular case, or how to balance the removal of an obstacle to productivity against an increase in financial costs for some—should be made only by a Minister, subject to Parliament'sagreement. They should not themselves be matters on which the court can substitute its own judgment.
	The Regulatory Reform Committee in another place, in its report on the draft Bill, as introduced to the Commons in January, was wary of,
	"passing to the courts the task of forming judgments about the outer edges of what is essentially political",
	and suggested the parliamentary veto as a way of addressing that. As noble Lords know, Parliament has a statutory veto over any proposed order.
	It seems to me, as the Minister, that this is right. It is appropriate that relevant parliamentary committees judge whether a particular order is appropriate, and, as the Commons Regulatory Reform Committee puts it, about,
	"what is essentially political",
	a point made by my noble friend Lord Borrie. While the court should be empowered to do so only in extremis there are occasions where the Minister may have disregarded the public law duty, and it is right to challenge that.
	The committees' judgment obviously will be informed by the evidence that the Minister provides in the explanatory document, which must be laid alongside the order. Among other things, that document ensures that there must be an explanation of the powers under which the order is made. It must introduce and give reasons for the provisions. It must explain why the Minister considers—

Baroness Wilcox: I hope that this will refresh the Minister, and perhaps I can get my own way on the Bill.
	In moving Amendment No. 2, I shall speak also to Amendments Nos. 3 and 4. This group of amendments seeks to test the process of consultation that is in place to deal with representations from business and organisations about the regulations to which they are subject. The process of initiating an order under Clause 1 begins with the Minister considering whether any order would serve the purpose of removing or reducing any burden, but there is no duty on the Minister to initiate such a process. We have tabled amendments, which will be debated later today, that impose a duty on Ministers to deregulate, but the purpose of this amendment is to make the consultation process on regulation more transparent.
	If a Minister does not think that a representation has merit or that the burden is not disproportionate, then this amendment would require the Minister to let Parliament know formally. This, we hope, would focus the minds of Ministers and their officials to justify why regulations that seem to be placing a disproportionate burden on business and individuals are remaining in force. More importantly, Parliament could see what regulations seem to be attracting the most amount of criticism. In addition, this would be a guaranteed way of ensuring that Parliament would see why the Minister has decided that the burdens complained of are proportionate.
	I draw support for this idea from the Better Regulation Task Force report to the Prime Minister entitled Less is More, which was published in March 2005. Recommendation 2 of that report states:
	"The Task Force recommends that by the end of 2005 the Regulatory Impact Unit in the Cabinet Office, should, in consultation with departments, develop a robust mechanism for the submission of proposals for simplification by business and other stakeholders. The mechanism should require businesses and other stakeholders to submit evidence in support of their proposals, with options for reform. It should require departments to respond within 90 working days, setting out and justifying the course of action they propose with a time limit for delivery".
	Our amendment seeks to get the ideas in this recommendation into statute. I understand that Clause 14 deals with the consultation process after the Minister has proposed to go ahead with an order, but could the Minister shed some light on the consultation process on existing regulations? In particular, I would welcome an update on the implementation of recommendation 2 of the report. What formal mechanisms are now up and running to vet individual representations about regulations? The Government's response to the report states that the full process for dealing with simplification proposals will be launched by December 2005. I ask the Minister: is this on course?
	I also understand that the Government were to submit to the Better Regulation Commission a six-monthly update on progress with the implementation of the recommendations. Can the Minister explain when that report, which is now due, will be available, and whether it will be made public? I beg to move.

Lord Bassam of Brighton: Amendments Nos. 5 and 53, as the noble Lord, Lord Maclennan of Rogart, explained, go in the same direction. The power to remove all the burdens resulting from legislation is, as noble Lords will understand, provided in Clause 1. As well as removing or reducing burdens, it could also introduce new burdens, so it may be helpful to explain some of the thinking behind Clause 1(2). As the noble Baroness said, I set some of that out in correspondence.
	First, Clause 1 permits the removal or reduction of any burden that results for any person from legislation. Removing or reducing a burden from one person may, however, as I think is now understood, increase burdens upon others. This reflects the situation under the 2001 Act and could allow, for example, a reduction of burdens on the regulated at the expense of an increase in burdens for regulators. Another example would be the introduction of more targeted, or proportionate, risk-based burdens; for example, a more efficient, risk-based inspection regime, where the burden of inspection is reduced on those judged to be low risk at the expense of more onerous inspections for those judged to be high risk.
	Secondly, Clause 1 also permits the removal or reduction of the overall burdens resulting for any person from legislation. This would permit an order to replace a scheme that imposes burdens on a person with another scheme that is less burdensome overall for that individual. New burdens could be imposed on a person if that was done in the context of reducing the overall burdens that result from legislation for that individual.
	As I said, that was possible under the 2001 Act. For example, the Regulatory Reform (Fire Safety) Order created one simple, risk-based fire safety regime applying to all buildings that the public might use. That reduced burdens on a large number of businesses, but the rationalisation also imposed new, proportionate burdens on some other businesses.
	Amendments Nos. 5 and 53 address the issue of whether orders should have to effect a net reduction in the level of burdens to which a person is subject. In calculating the net level of burdens, it is important to remember that the measurement of burdens is not an exact science. It is difficult to compare the relative impacts of burdens, given the definition of "burden" in Clause 1. These are issues of judgment based on evidence—evidence that, as we discussed, the Minister will weigh and which the parliamentary committees will rightly challenge and confirm where appropriate. For example, Amendment No. 53 seeks to impose an additional precondition stating that any new or increased burdens can be imposed on one person only to the extent necessary for the removal or reduction of burdens on others, and the new or increased burdens must be proportionate to that purpose.
	In any case, the precondition in Clause 4(2)(c) requires that the provisions of an order, taken as a whole, must strike,
	"a fair balance between the public interest and the interests of any person adversely affected by it".
	This would ensure that any new burdens imposed by an order were considered in terms of the wider public interest.
	Amendment No. 53 would require that an administrative inconvenience may have to be weighted against an obstacle to productivity or a sanction. In many cases we can calculate in monetary terms the impact that the removal or reduction of these burdens would have. But in some cases—for example, that of administrative inconvenience falling upon individuals—the administrative inconvenience may not impose a financial cost. In these cases, the different types of burdens being added and removed could be incommensurable, and it would therefore be impossible to compare the burdens imposed on one person with the burdens removed from another.
	Amendments Nos. 53 and 5, therefore, would in many cases dramatically increase the analytical work that would be needed to deliver an order, replicating one of the major problems with the 2001 Act about which there have been complaints, and slow down the pace of regulatory reform by order. In some cases, it would simply not be possible to calculate whether the level of burdens overall had been reduced. The task would be like trying to compare chalk and cheese, so it would not be possible to deliver a beneficial reform by order. I should make it clear that Clause 1(2) allows orders to remove or reduce a burden. The second purpose of removing or reducing overall burdens makes it explicit that new burdens can be imposed on a person where overall burdens for that person are reduced. Since the purpose of the Bill is regulatory reform and cutting bureaucracy, it would be wholly inappropriate for orders to be used to create unnecessary burdens.
	Clause 15 provides that, for orders made under Clause 1, the explanatory document laid before Parliament must include details of the consultation responses received, which could highlight the creation of any unnecessary burdens. The document must also explain why the Minister considers that the preconditions in Clause 4, which include proportionality, are met, and must include an assessment of the extent to which the provision made by the order would remove or reduce any burden or burdens. It is government policy that, where appropriate, measures should include full impact assessments.
	The amendments tabled by the Government provide the parliamentary scrutiny committees with the power to veto proposals that they consider inappropriate for delivery by order, and I would expect that proposals that significantly increased red tape would fall foul of that test. As I have explained, the Bill already provides Parliament with an opportunity to assess the impact of any new or increased burdens and to consider the views of those affected. Amendments Nos. 53 and 5 would slow down the order-making process and could prevent beneficial reforms from being delivered by order. In such instances, we would consider that the Bill, which is designed to speed things up and improve the process, had failed in one of its important objectives.
	The second type of failure might be the creation of powers that do not work in practice—for example, because sensible consolidation or the addition of new and better targeted burdens is not possible as part of wide-scale regulatory reform. We might also replicate the problems arising from the 2001 Act and make the powers so complex to use in practice that a prohibitive amount of analysis—as proposed by the amendment—would be required in order to create an order. It is vital to avoid this. None of us wants to be here in four or five years debating another reform Bill, while businesses and others are still waiting for what we think and they think is an effective vehicle to deliver sensible cuts in red tape.
	The third type of failure that we must avoid would be when orders could be used to deliver proposals that did not have better regulation benefits, including entirely new policies such as major education or health reforms or proposals that implemented burdensome regulatory regimes. The order-making powers in Clauses 1 and 2 are drafted to prevent that but, as the Parliamentary Under-Secretary of State for the Cabinet Office, Pat McFadden, said in another place, we must beware that our efforts to refine the order-making power do not lead us into the second pitfall that I mentioned, so that we end up with a beautiful parliamentary process but not one that has a beautiful, useful deregulatory outcome.
	In view of those comments, I hope that the noble Baroness and the noble Lord will feel able not to press their amendments and will reflect carefully on the points made in the debate.

Lord Tebbit: This is what I would describe as a sporting amendment. Although it consists of only nine words, it would have a substantial effect on the Bill and would, if accepted, require substantial consequential amendments. However, if the Committee were to agree to its intent, I do not think that it would be too technically difficult to produce those amendments in time for Report.
	The strongest and most well-founded criticism of the Bill is that it would, particularly in the form in which it was introduced in another place, give excessive powers to Ministers to repeal, amend or enact primary legislation without gaining appropriate parliamentary consent. Indeed, it came pretty close in its original form to being a Bill to enable Ministers to take such powers to do such things as they thought they should do without any debate or parliamentary consent. I am sure that all of us who have been Ministers have dreamt quietly at some time in our offices of having such powers. However, in my view—this view also came over very much in the speeches earlier today of my noble friend Lord Jenkin and others—the Bill is still too wide and too deep in its coverage and it would give more power to Ministers than Ministers should really have.
	The intent of the amendment is to restrict the powers of Ministers under the Bill to amend, annul or create regulations and legislation to those regulations and legislation that have been created under the powers granted by Section 2 of the European Communities Act 1972. As I mentioned today, those powers are enormously wide. There is not much doubt in my mind, or in most of our minds, that most of the mischief that Ministers say needs to be addressed by this Bill derives from Brussels. That is where most of the irksome, burdensome regulations have come from. The Bill, as I would amend it, would leave those powers there to deal with that Brussels legislation. However, it would deny the powers that the Government have sought to amend primary legislation—and, indeed, regulations—without normal parliamentary procedures. In my judgment—which I think my noble friend Lord Onslow shares—giving such powers to the Executive is really like offering free intoxicating liquor to alcoholics: they will take it—they will grab it—and they will use it.
	My amendment would also remove powers, which might still remain in the Bill, to repeal, make or amend secondary legislation made under Westminster primary legislation. I do not think that Ministers can object to that. They always say that the regulations that they have made are wise, sensible and needed, and that they have not really made very many of them, so it would not be very often that they would want to replace them. It seems to me quite reasonable that when they do want to replace or amend such regulations, they should use their existing powers to deal with them. Wherever a regulation had been made, they would have a power to unmake it. If they deemed that those powers were inadequate, they could argue for them to be increased—perhaps, as was suggested earlier, in a Bill to amend the 2001 Act to make it more convenient to use.
	I hope that the simplification of the Bill will appeal not least to the noble Lord, Lord Bassam, and even more to my noble friends on the Front Bench. I am sure that they will be attracted to restricting the Bill solely to dealing with regulations and other legislation made under the 1972 Act. I can see that my noble friend Lord Waddington is anxious to remind me of his amendment, which comes later. I beg to move.

Lord Waddington: I am not sure that my noble friend's main purpose in moving his amendment was to give publicity to my amendment but it is a useful trailer. It is not exactly a paving amendment but it directs the Committee's attention to Amendment No. 30, which, put in the simplest terms, would provide a machinery, if Parliament so willed it, to reverse provisions which had become law because of the operation of Section 2 of the 1972 Act. It is absolutely certain, as I hope every noble Lord in this Chamber will agree, that a deregulatory measure which does not recognise that most of the burdens on business originate in Europe is mere window-dressing.
	I remind the Committee of certain remarks made by the noble Lord, Lord Bassam, at Second Reading on 13 June. He said, as if it were a matter for congratulation:
	"The Commission has dropped more than 65 proposed pieces of legislation and has undertaken to simplify up to 1,400 individual pieces of Community legislation ".—[Official Report, 13/06/06; col. 123.]
	He said that as a sort of puff for the Commission, suggesting that its heart was in deregulation. But that form of words was deliberately created to conceal the truth. If you read the words carefully, you will see that the Commission is in fact saying that it has not reversed one single provision which has become law since it was invented and that it has not the slightest intention of reversing one single piece of law which it has created since it was invented. It is saying only that it has scrapped some of the nonsense which was in the pipeline and that it is prepared to see whether it can simplify certain other measures. It is a denial of any intention by the Commission to deregulate, and people had better recognise that.
	The Bill currently does not provide the power to deal with regulatory burdens imposed on business by operation of the 1972 Act. If there had been such a provision in law, if Parliament had so willed and if it had been prepared to face the consequences—because there would have been consequences—it could have dealt with the situation mentioned earlier by my noble friend Lord Tebbit. It could, if it so willed, have said, "We will not have those provisions applied to the Armed Forces and, using the provision invented by the noble Lord, Lord Waddington"—in fact, not invented by him at all but adopted by him after it had been invented by Mr Cash in the House of Commons—"we will reverse what otherwise would have been of effect as a result of Section 2 of the 1972 Act".
	To remove the mass of burdens on industry, Parliament needs the sort of provision contained in Amendment No. 30. We will come to that later. I need say no more, but that would give meaning to the expression of will contained in my noble friend's amendment, which I heartedly support.

Lord Desai: I am very grateful for that explanation. I shall have to think about it between now and Report stage. I may return to it. A later amendment states that one of the sacrosanct Acts that the Bill shall not be allowed to amend is the European Communities Act 1972. There would be conflict between this amendment and a later one as people may want to protect our constitutional rights and preserve all those Acts. I have no doubt that there are various snares and traps awaiting me. I hope someone will clarify what this is all about.

Baroness Wilcox: My noble friend's sporting amendment, as he referred to it, is typically ingenious and provocative. He is right to draw attention to the fact that, as things now stand, bureaucrats in Brussels may make orders that bind the Parliament of the United Kingdom without this House having any effective power to stop them, while there would be cries of outrage from Europhiles that any parallel order-making power might be conferred on our own bureaucrats to make orders to do away with European Union legislation. That goes to show that there is a one-sided relationship between the United Kingdom Parliament and the European Union bureaucracy, to which the Government would do well to give more serious attention than they have in the past nine years. Indeed, in the past nine years it has seemed as if an unofficial competition has been running between government departments, not about which could remove most EU regulation, but which could gold-plate an EU regulation in the most extravagant and burdensome way.
	-Few things have more typified the empty spin and ineptitude of the Prime Minister than his parrot cry that the debate in Europe is coming our way, while all that really comes our way are bucket loads of new draft regulations. Most of us have given up hoping that anything will be done while the Government are in power. They have constantly spoken of deregulation, but all they have done is regulate, regulate, regulate, with gold-plating of EU directives at the heart of it.
	I regret to say that this is the fault not only of Ministers but of Permanent Secretaries in departments that have failed to get a grip on the regulation mania that seems to beset public administration in Europe, slowly but surely strangling our international competitiveness. It is high time that some kind of limit was placed on the amount of legislation and regulation that each department can pass. A little less thoughtless regulation and a little more thoughtful administration would do us all a power of good.
	I agree with the basic spirit of my noble friend's amendment, but I am sorry to say that I cannot support it. As drafted, it confines the deregulating powers to dealing with EU legislation only; whereas if we can agree an acceptable mechanism subject to proper parliamentary control, it should apply to UK regulation as well. Furthermore, I do not think that an order-making provision of this kind would ever be used by the current bunch of Ministers. Can you image our Prime Minister going into the European Union Council with 10 draft orders under his arm, warning the assembled heads of government that unless they stop trying to control our immigration policy, he will lay an order legalising the use of pounds and ounces in Sunderland market? He would make no such orders. When he goes to the Council, he is too busy making concessions.
	Despite my sympathy with my noble friend, therefore, any change in our workings within the EU and its legislative powers should follow specific parliamentary debate on primary legislation. In conclusion, however, I ask the Minister not to brush aside the issues underlying an important amendment. I ask him to tell the Committee frankly whether he is satisfied with the current weight of EU regulation and our capacity to deal with and scrutinise it, and, if he is not, what he is going to do about it for us. As part of that, will the Minister tell us how many EU regulations he has managed to have repealed in the past six months? His officials will no doubt be able to supply that information before the end of the debate. I have asked for information on only six months, as it is those triumphs that will no doubt be uppermost in the Minister's mind as he rises to speak.

Lord Bassam of Brighton: The amendment of the noble Lord, Lord Tebbit, is certainly "sporting"; there is no doubt about that. It has probably led to a bit of grief on the Front Bench opposite, because there is clearly a sharp difference of opinion. The 1972 Act was enacted not by a Labour Government but by a Conservative Government. I am always pleased to see that the noble Lord, Lord Tebbit, has not changed in his general scepticism of all things European. It is refreshing to have a distinct view expressed in this Committee, and the noble Lord does it very well indeed.
	I have been invited to comment on the amendment of the noble Lord, Lord Waddington. Unless the noble Lord is not going to move it, I think that we should save that debate until later. But there is not much to choose between the comments and propositions of the noble Lords, Lord Waddington and Lord Tebbit. They might be acting in concert, and that is fair enough.
	The noble Lord, Lord Waddington, made one point to which I wanted to respond. He reflected on my comments at Second Reading and in the debate on European regulation inspired a while ago by the noble Lord, Lord Grenfell. We are proud of our role in encouraging a deregulatory approach by the EU. The EU is perhaps in some respects a bit behind the UK in attempting to deregulate. That is not the case for all EU states. Some are perhaps a bit more advanced, but most are behind us. They are now recognising that we have a robust approach. I reject the allegation that we gold-plate EU regulations because that is not our intention at all.
	The power to remove or reduce burdens should certainly be used to remove gold-plating, and the Davidson review is currently considering evidence about gold-plating. That review will report later this year, and, if appropriate, the Government will use powers in this and other legislation to ensure that we do not gold-plate, because that is not what we want to achieve.
	As to the amendment tabled by the noble Lord, Lord Tebbit, I wonder whether he really wishes to limit the order-making power in Clause 1 to remove and reduce only those burdens resulting from legislation made under the powers granted by the European Communities Act 1972. I think that he ultimately does not wish to do that, because he spoke with eloquence earlier on the need to restrain regulatory activity by governments—not only this Government but all governments. We argue that it is more sensible to remove or reduce by order burdens resulting from any legislation and regardless of whether they originate from the European Community. As this amendment would impose an unnecessary restriction on the order-making power in Clause 1, I urge noble Lords, whether they be Front-Bench Conservative Peers or not, to reject it.
	It is worth reminding ourselves of the value of Section 2(2) of the European Communities Act. It makes provision for a Minister or a department to implement European Community obligations into domestic law by regulation. I know that noble Lords do not always agree with them, but there are many benefits in adopting rules set at European level. For example, the legislation underpinning the common customs union means that the UK can import from and export to all other EU members without having to face 24 different sets of rules and duties. That seems an entirely sensible approach. EU legislation which we transposed into UK legislation opened the national telecommunications market to competition in 1998. Breaking those national monopolies helped to bring down the cost of calls by 40 per cent to 50 per cent. Although I could quote many other examples of the valuable transposition of EU regulatory regimes into UK law, and there might be some benefit in doing so, those two examples alone are sufficiently important examples.
	The noble Baroness asked me to give a figure for the number of EU regulations scrapped in the past six months. I do not have that information to hand and suspect that she did not expect me to. Perhaps I should have had it. But I am happy to write to her and to share the fruits of the correspondence with other noble Lords who have contributed to our debate.

Lord Bassam of Brighton: The noble Baroness asks a simple enough question, but, as with all these things, the question raises many others. First, there is the issue of defining burdens. Clause 1 does that by setting out whether they are financial, administrative, an obstacle to efficiency, productivity or profitability, or a sanction, including criminal sanctions. The definition of "burden" is broader than that in the 2001 Act. That is why we decided to amend the 2001 Act. We have managed to achieve things under the 2001 Act, but we want to do more. In that Act, there was a power to reduce or remove a burden defined as a sanction, criminal or otherwise, where it was an integral and appropriate part of reducing the burden on the regulated.
	A good example of that was the Regulatory Reform (Fire Safety) Order, which simplified and rationalised existing fire safety legislation spread over 50 pieces of legislation. By reducing burdens on business in that instance, we saved time caused by the multiplicity of overlapping fire safety regimes that had to be satisfied and the overlap of responsibility for enforcement. There was not just the fire authority and the fire service, but the local authority, together with building control officers, and so on. They all seemed to be working on the same problem.
	Through this process, we are attempting to achieve a greater coherence and simplification of the process and how it impacts on people. Amendment No. 8 is intended to add to the definition of burdens. Subsection 1(3)(a) provides that burdens which can be removed or reduced by order include financial costs. Amendment No. 8 adds,
	"significant quantifiable cost in time",
	to that limb of the definition of burdens. I argue that the amendment is unnecessary. The definition of burdens already includes opportunity costs—in other words, the time a business spends complying with a regulation when it could usefully be doing something else. This would count as an obstacle to productivity, which Clause 1(3)(c) already provides for, and is a burden for the purposes of the Bill.
	Clause 1(3)(c) covers the loss of a financial benefit due to the time spent complying with a regulation. The definition of burden as an administrative inconvenience would also permit the removal or reduction of burdens resulting from legislation that do not actually impose financial costs but do impose administrative burdens, many of which are hard to quantify. This is particularly true of the time that they take, because one cannot be absolutely precise about the nature or the amount of time that an administrative act will take.
	We sympathise with the spirit of the noble Baroness's amendment, but we believe it to be unnecessary because in essence it is taken account of in the legislation. The issue is very much at the core of the debate about burdens and regulation, so I congratulate the noble Baroness on tabling the amendment.

Viscount Goschen: I ask the Minister not to dwell each time on fire safety legislation. He will recall when we considered the 2001 Bill, as it was then, that almost the only example that the Government could come up with at every opportunity was fire safety legislation. It would be a great shame to draw a very broad-reaching power that could amend any Act on the statute book just to get at the fire safety legislation. I am sure that it would assist the House if, during our consideration of the Bill, the Minister could ponder with his officials other areas that may be affected.

The Earl of Onslow: Surely we do not need an Act of Parliament to stop people filling in a form. Someone in an office says, "Change the form". You do not have to be a genius to do that. The Minister has just said that "administrative inconvenience" could be filling in forms. Surely we do not need an Act of Parliament to stop people filling in forms. Just do not send them out, change them or make them smaller. An Act of Parliament is not needed for that.

Lord Peyton of Yeovil: I rise to say only that in my anxiety to understand what is really quite a trifling point, I shall certainly read with great care what the noble Lord has said in the hope that it might bring light into the darkness.

Lord Howard of Rising: I accept that. The Minister says that it is not about the big issues, but about removing burdens. However, this House should look at what the Bill says, not at what the Minister tells us is his interpretation of what it says. I personally do not share his rather charming faith that future generations will not try to abuse legislation that is capable of being abused. That having been said, for the time being I beg leave to withdraw the amendment.

Baroness Wilcox: I have tabled this amendment because I cannot find the word "risk" in the Bill. In the review published by Philip Hampton in March 2005, the concept of risk assessment as the basis for regulatory intervention was expounded at length. I cite Recommendation 1 of the review:
	"The review recommends that all regulatory activity should be on the basis of a clear, comprehensive risk assessment".
	It goes on to state that:
	"The risk assessment should be balanced in including past performance and potential future risk".
	No doubt we will discuss how the Hampton review has been incorporated into the regulatory principles set out in Part 2, but I wonder why the concepts of proportionality and risk do not apply to the meaning of "burden" in this clause.
	All we hear about the concept of proportionality in Clause 4 is that the effect of any provision in Clause 1 has to be "proportionate to the policy objective". But no mention is made of regulations having to be proportionate to risk or, indeed, that a Clause 1 order should focus on burdens that are disproportionate to risk, even though risk is set up by Philip Hampton as the measure against which regulatory activity should be compared. To measure a particular Clause 1 order against a policy objective is not the same as measuring a particular order against an objective standard of risk and the need to ensure that regulations are proportionate to the risk involved in not intervening.
	I accept that the Minister has powers to promote regulatory principles under the powers proposed in Clause 2(3), which states:
	"Those principles are that—
	(a) regulatory activities should be carried out in a way which is ... proportionate".
	Why is the concept of proportionality not expressly couched in the language of risk, which is such an important recommendation in the Hampton review? I beg to move.

Lord Bassam of Brighton: That, of course, being the case, it could be down to interpretation.
	Anyway, to get to the point, Amendment No. 11 seeks to add the words "identifiable risk" into the definition of "burdens" in Clause 1. The noble Lord, Lord Borrie, has put his finger on why we do not need the amendment.
	The amendment is unnecessary. Health and safety regulations which are disproportionate to identifiable risk could be removed under the existing definition of "burdens" in Clause 1(3). The amendment alludes to a situation, for instance, where a business is inspected very frequently but that business has a good track record on health and safety and the evidence suggests that the level of inspections is disproportionate to the risk that the business poses. But this over-inspection, of course, imposes a financial cost and an administrative inconvenience on the business. It also imposes a cost on the regulators because they have to submit themselves to extra time and energy costs in enforcing the regulations unnecessarily. We contend that such situations are already covered by the definition of "burdens" in Clause 1(3). Amendment No. 11 is unnecessary because it will not add to the definitions of "burdens" which are already in the clause.
	I am heartened by some of the debate because it is clear that both sides of the Committee have in their sights the same sorts of problems and issues. If we continue in that vein, I think the noble Earl, Lord Onslow, and I will end up agreeing with each other rather more than we have ever agreed with each other in the past. Noble Lords will probably think that is a good thing.

Baroness Wilcox: I have listened carefully to every contribution and got rather lost along the way. Letme go back to the point that the noble Lord, Lord Goodhart, whose support I was delighted to have, and I were making. If one goes to the trouble of letting Philip Hampton undertake this great review which is so well received by all, when he uses particular language and has a particular way of saying things, it seems wrong not to use the words that he is using. In addition, the public understand what is meant by "risk". They understand the concept of risk. I understand what is meant by the concepts of risk and proportionality.
	I listened carefully to the noble Lord, Lord Borrie, for whom I have the greatest respect. When he was the Director-General of Fair Trading, I was chairman of the National Consumer Council, and I learnt to make sure that I used the words he used, because I had far more chance of getting things past him if I did. I am asking the Minister to use the words of the Hampton review here. I cannot see why his advisers are taking him round in circles to avoid using it. It seems very strange.
	I will read what has been said, among all the other entertaining things which have been said here today. It is a very serious point. The concept of risk is very serious, certainly in health and safety legislation. I shall return to this at Report, by which time I hope the Minister will have spoken to his advisers, looked at the Hampton review recommendations and come back with wording on which we can all agree. In the mean time, I beg leave to withdraw the amendment.

Lord Peyton of Yeovil: I remind your Lordships, particularly the Minister, that Clause 1(3)(d) refers to,
	"a sanction, criminal or otherwise, for doing or not doing anything in the course of any activity".
	In the interest of economy of space—this is not a complicated point—it might be nice to leave out the words "or otherwise" and leave the provision referring to "a sanction".
	Can the Minister please explain, in words I can understand, what is added to the Bill by the inclusion of those two very simple words "or otherwise"? My contention is that the words "a sanction" have the same meaning, so "or otherwise" could safely be left out. This is one of the very few times in my life when I am really confident that the Minister cannot resist the argument to leave out these two words, but of course my life is one of perpetual disappointment in this context. I beg to move.

Lord Norton of Louth: I have three amendments in this group, so I should like to develop the case for them and, to some extent, reiterate what my noble friend Lord Peyton has said.
	In tabling those amendments, I start with two propositions. First, the terms of the Bill should be as tightly drawn as possible. As we have already discussed, the potential for misuse by future Governments remains considerable. If it is to be used for removing non-contentious regulatory burdens, it needs to be clearly and firmly ring-fenced. That is the generic point I begin with.
	My second proposition is that one of the most powerful weapons in the armoury of Parliament is to stipulate conditions under which the individual can be deprived of liberty. Parliament can stipulate what is and what is not an offence, and can provide that anyone convicted of an offence may lose their liberty for a stipulated period. Given the importance that we attach to the liberty of the individual, I believe that we must be circumspect in providing that anybody other than Parliament can prescribe specified offences carrying terms of imprisonment. If someone is to be deprived of their liberty, we need to be sure that Parliament has made the decision as to the offence and the penalty.
	If Parliament has previously made a decision as to an offence carrying a penalty that may entail going to jail, then it has to be assumed that it has done so in the full knowledge of the seriousness of what it has done. Similarly, if penalties carrying terms of imprisonment are to be introduced, they should be introduced by Parliament. In short, Parliament should be the body that determines the circumstances in which the individual may be deprived of their liberty. That may involve creating offences and it may involve repealing offences.
	As my noble friend has outlined, Clause 1 provides that the Minister may make an order to reduce a burden where that burden may comprise,
	"a sanction, criminal or otherwise, for doing or not doing anything in the course of any activity".
	Clause 7 permits an order to be made creating a new offence that is punishable on indictment with a term not exceeding two years or on summary conviction with imprisonment for a term not exceeding the normal maximum term or a fine not exceeding level 5 on the standard scale.
	I appreciate that the noble Lord, Lord Bassam, will respond that such orders will be subject to parliamentary scrutiny under the Bill. However, I believe that offences carrying terms of imprisonment created by Parliament through primary legislation should normally be repealed by Parliament through primary legislation. As I read the Bill, Clause 1 permits an order to get rid of any criminal offence, whatever the penalty. Similarly, if a criminal offence is to be created, especially one which entails a term of imprisonment, it should be created through primary legislation.
	My amendments are designed to address the point, albeit in different ways. Amendment No. 13 follows the amendment of my noble friend Lord Peyton in removing the power to remove the criminal offence by an order under the Bill. This amendment takes my argument to its logical conclusion and reserves to Parliament the right to abolish a criminal offence through primary legislation. However, I appreciate that there is an argument that certain regulatory burdens may be created through offences that may entail fines or a short period of imprisonment. So I can see that there may be an arguable case for allowing for the removal of such offences by order. It is for the House to determine where to draw the line—removing such a power altogether or permitting it in limited circumstances.
	Under Amendment No. 15, primary legislation would be required to remove any offences carrying a penalty of imprisonment for more than two years. Since I tabled that amendment, the noble Lord, Lord Goodhart, has tabled Amendment No. 74, which seeks to achieve a similar result but in a more sophisticated and, I think, preferable manner. I will be happy to support that amendment.
	The argument I have deployed applies also but with more force to the power to create new offences. Again, if we take my argument to its logical conclusion and reserve to Parliament the right to create criminal offences through primary legislation, then Clause 7 should come out of the Bill. Alternatively, instead of removing it, one may seek to restrict further the powers it contains by deleting the capacity to create an indictable offence. That is the intention of Amendment No. 72.
	It is for Parliament to decide where to draw the line. I do not believe that removing, or at least limiting, the capacity to create or remove criminal offences creates insuperable problems in seeking to achieve better regulation. I know that the Minister will argue that it does, but if departments identify offences which should be removed or created and which cannot be because of these amendments, they could be included in an annual deregulation Bill as proposed by my noble friend Lord Goschen at Second Reading. Indeed, I would regard an annual deregulation Bill as a preferable alternative to this Bill, but if the Government persist with this measure, a regular deregulation Bill may complement it. That possibility provides the basis for ensuring that this Bill is as tightly drawn as possible. As we have discussed, it is too open-ended as it stands, not least in respect of matters that should be prescribed by Parliament through primary legislation.
	The Minister has argued that there needs to be some scope for removing a sanction. He developed the point in his letter—it is becoming his infamous letter—of 27 June. My response to that is, "Yes—up to a point". My amendments are designed to establish where that point lies.

Lord Goodhart: Amendment No. 74 would insert a new clause with three subsections. I am effectively degrouping subsection (3) from subsections (1) and (2) of our new clause. Subsections (1) and (2) are wholly on the same lines as Amendment No. 15 of the noble Lord, Lord Norton, and are a necessary part of this debate, whereas subsection (3)—I should probably never have grouped them together to begin with—raises an entirely different debate with which there will be an opportunity to deal next week. It is not a formal degrouping—I accept that that is not possible.
	I am unable to support Amendment No. 13 because, first, a power to create offences with a penalty of up to two years is already contained in the 2001 Act. A significant case would therefore have to be made for deleting it from the new Bill. Secondly, new offences will in practice need to be created by orders made under this Bill where they replace previous regulations which have contained criminal sanctions.
	It is clear that if relatively minor offences can be created under existing legislation or under this Bill, then it is appropriate to have an equivalent power to abolish them. However, offences carrying higher penalties should not be abolished without a full debate and full proceedings by primary legislation. For example, it would be wholly inappropriate to decriminalise drugs, if a future government decided to do so, without primary legislation covering such a serious crime. The same principle applies where the offence is retained but the maximum penalty for it is reduced. I have nothing to add to what the noble Lord, Lord Norton, said, because I am entirely in agreement with the principle behind his Amendment No. 15.

Lord Borrie: Perhaps I may speak to the amendment of the noble Lord, Lord Peyton of Yeovil, and those of the noble Lord, Lord Norton of Louth. So far as the amendment of the noble Lord, Lord Peyton, is concerned, if the words "criminal or otherwise" were left out, the outcome would be exactly the same. I therefore agree with the noble Lord, Lord Peyton. But there may be a case that the Minister might wish to use, which is that if you use the words "criminal or otherwise" in the Bill, for the sake of three extra words you provide greater clarity and remove any doubt that some people might have that it did not apply to both criminal and civil sanctions. So there may be a case for it in terms of clarity, but otherwise I agree with the noble Lord.
	As for the proposals of the noble Lord, Lord Norton, for the reasons enunciated by the noble Lord, Lord Goodhart, it would be a very bad thing to go with his Amendment No. 13. There are numerous types of defences, both of the more serious type to which the noble Lord, Lord Goodhart, referred and what are sometimes called statutory offences with modest fines imposed. There is a world of difference between them. But there is a great deal to be said for the more substantial point raised by the noble Lord, Lord Norton, under the other amendment, supported by the noble Lord, Lord Goodhart. I do not know whether the amendments are rightly worded, and I look forward to hearing the Minister's response as much as any other noble Lord.

Lord Henley: Before I comment on the particular amendments, I remind the Minister about the rubric that appears at the top of the list of groupings for this Bill and for that matter any other Bill. He made a strange face when the noble Lord, Lord Goodhart, suggested that he might want to degroup his Amendment No. 74, or part of it. I remind the Minister that the rubric at the top of the list of groupings says:
	"Although every effort is made to secure agreement to these groupings, they remain informal and not binding. It is therefore open to any Peer to speak to an amendment in its place in the Marshalled List".
	That applies whether any noble Lord wishes to degroup amendments or not. I remind the Minister that the list of groupings is there for the convenience of the Committee and not of the Government or Ministers.
	The three amendments tabled by my noble friends and the fourth, tabled by the noble Lord, Lord Goodhart, have as their aim the limitation of the order-making powers to non-criminal sanctions only. I note that the Regulatory Reform Act 2001 includes criminal sanctions in the remit of regulatory reform orders. It describes a burden as,
	"any sanction (whether criminal or otherwise) for failure to observe a restriction or to comply with a requirement or condition".
	But that does not mean that the appropriateness of including this type of sanction within the meaning of burden should not be revisited.
	In the debate on the 2001 Act, the inclusion of criminal sanctions within the meaning of the burden did not receive a great deal of attention in Committee. Perhaps it should have done, but I cannot remember the debates at the time. Its inclusion here has not been expressly highlighted by the Select Committee on the Constitution or the Delegated Powers and Regulatory Reform Committee—but they were examining the Bill with the precedent of the 2001 Act in mind.
	With three separate amendments in the names of three separate of my noble friends, I do not want to act as Paris in choosing between the three amendments. But no doubt the Minister will adjudicate between those three and that part of the amendment in the name of the noble Lord, Lord Goodhart, to which he spoke. The Government have already accepted a limitation to the order-making power when dealing with the creation of new offences in Clause 7, which we will get to in due course. Subsection (1) of that clause says that an order cannot create a new offence with a penalty of more than two years' imprisonment or increase a penalty for an existing offence up to the same limit of two years. It therefore seems to accept that when creating or increasing offences those carrying a sentence of more than two years should be the preserve of primary legislation. If that is the case, then when it comes to reducing a burden—and if the same principle were to apply—offences that Parliament has already deemed to merit a two-year sentence or more should likewise be the preserve solely of primary legislation.
	What would be useful to set this debate in context would be if the Minister could set out how many new offences if any have been created or removed under the existing regulatory reform order procedure and what increases to sentences have been made. I hope that the Minister can give us an answer on that this evening.

The Earl of Onslow: Could we also please have some examples of what the Minister would like to do to remove or to add to minor criminal offences? It seems perfectly reasonable to alter parking regulations which may be over-burdensome in that way, especially as they probably arise as regulatory offences anyway. I do not think that one can complain about that. But what things do the Government have in mind which they would like to change, and under which Act? All that we have had so far is blowing the trumpet of the fire regulations and then saying that the Game Act 1831 needs repeal. To add into English law more powers to allow Ministers to amend primary legislation just because of the Game Act 1831 seems a disproportionate constitutional reaction. Can we please have some concrete examples of where the Government think things are wrong? That is what we are always trying to get at.

Lord Bassam of Brighton: I am grateful to the noble Lord for that elucidation.
	I have made the case in the past that to make and deliver better regulation we need to be able to repeal offences or reduce or remove sanctions for offences when they are considered no longer to be targeted or appropriate. An example of the reduction or removal of regulatory sanctions might be changing the sanctions connected to breaching a licensing regime for a particular activity. I have explained that in earlier debates. It is not new. Regulatory reform orders under the 2001 Act could reform legislation which imposed burdens, including sanctions, criminal or otherwise, affecting persons in the carrying on of an activity, because of the definition of burden in Section 2 (1) of the 2001 Act.
	The definition in this Bill is narrower than that in the 2001 Act. In the Bill, the definition of sanctions, criminal or otherwise, means that an order can remove or reduce only criminal sanctions which relate to the carrying on of an activity. This means that sanctions relating to offences under the general criminal law cannot be repealed or reduced, as opposed to what the noble Lord, Lord Norton, said. It would not be possible, for example, to remove or reduce by order sanctions for murder, rape or burglary. This is an important and essential safeguard against any inappropriate use of the order-making power in Clause 1. I know that noble Lords have been very exercised by that issue.
	Amendment No. 14, proposed by the noble Lord, Lord Jenkin, would have the effect that this restriction would be removed. I imagine that this is not the effect which the noble Lord intended, and as the Government also prefer to make explicit that the order-making powers are limited to removing or reducing sanctions which relate to the carrying on of an activity, I hope that the noble Lord will withdraw his amendment.
	I return to why this definition of burdens is necessary to deliver better regulation. Professor Richard Macrory, Professor of Environmental Law at UCL, has been appointed by the Government to carry out an independent review of the sanctions regimes used by regulators and local authorities. He notes that:
	"Sanctions are an important part of any regulatory system. They provide a deterrent and can act as a catalyst to ensure that regulations are complied with".
	That may be stating the obvious, but it is important as it spells out exactly why regulations are necessary. I think we all agree that effective regulations and sanctions regimes play a critical part in regulating and encouraging proper behaviour. Professor Macrory's recommendations are likely to involve significant changes to the entire penalties regime to make it more responsive and more proportionate, and this Bill is not a substitute for that work. It is clear, however, that having a flexible, proportionate and responsive sanctions regime is a key part of any regulatory toolkit, and of the better regulation agenda.
	I should give an example of why this definition of burden is necessary to deliver sensible reform to established regulatory systems that have a real impact on those on the ground bound by the rules. Members of the Committee may have heard me mention at Second Reading that stakeholders have submitted, via the Government's internet site, a proposal to repeal arcane rules on selling game. The noble Earl, Lord Onslow, asked me not to quote this example, but it is a good one and I shall do so.

Lord Bassam of Brighton: I have made it clear that we are not changing the constitution and that we need to address issues such as these because they present burdens. The Game Act 1831 and the Game Licences Act 1860 impose burdens. The Government have committed to deal with those and so save businesses across the country tens of thousands of pounds. The reform is necessary because the 19th century regime is now clearly out of date as a result of economic, social and legislative changes.
	The Government also propose to deliver reform by order so that we can usefully tackle other issues such as game dealing licences that are required under the Act. To do so, it will be necessary to repeal the criminal offences associated with carrying out certain activities without the following licences: licences to take or kill game under the Game Act 1831 and the Game Licences Act 1860; licences to deal in game granted under Section 18 of the Game Act 1831, as extended by Section 13 of the Game Licences Act 1860; and excise licence under Section 14 of the Game Licenses Act 1860.
	Under the present Act it is possible to deliver this reform by order. It is the Government's view that useful legislative reform such as the above, which reduces burdens on the regulated, but which is too small to merit a Bill should continue to be possible by order under the present Bill.
	The Bill also carries over the ability under the present Act, by order to replace sanctions with new sanctions or to create new sanctions. The fire safety regulatory reform order has attracted criticism and is an oft quoted example, but I shall use it again, though I am committed to undertaking further research on the subject. The RRO delivered under the 2001 Act is a good illustration of why it is necessary to deliver regulatory reform of a whole regime. As I said, the fire safety RRO delivered under the 2001 Act replaced a whole raft of legislation with one simple, risk-based fire safety regime, but it was necessary to replace the divergent systems of sanctions for non-compliance across 50 pieces of legislation. This was possible only because the Government were able to remove the burden created by the old sanctions for non-compliance and replace these with one harmonised, transparent, targeted and appropriate new system of sanctions.
	The Committee will, of course, be aware that Clause 7 restricts what orders can do in respect of criminal penalties: for example, orders cannot make provision to create a new offence that is punishable on indictment by more than two years' imprisonment. This and further safeguards are in place governing the use of the order-making power, including its use to repeal or reduce sanctions, criminal or otherwise. The Minister making the order must be satisfied that the preconditions in Clause 4 are met: that the policy objective intended to be secured by the provision could not be satisfactorily secured by non-legislative means; that the effect of the provision is proportionate to the policy objective; that the provision taken as a whole strikes a fair balance between the public interest and the interests of any person adversely affected by it; that the provision does not remove any necessary protection; and that the provision does not prevent any person continuing to exercise any right or freedom which that person might reasonably expect to continue to exercise. As the Committee knows, relevant parliamentary committees will have the statutory power to veto any order.
	I hope that, having heard that explanation, Members of the Committee will not press Amendments Nos. 12, 13 and 14.
	Amendment No. 72, which stands in the name of the noble Lord, Lord Norton of Louth, would delete the safeguard in Clause 7(1)(a) which ensures that an order may not make provision to create a new offence that is punishable, or increase the penalty for an existing offence so that it is punishable on indictment, with imprisonment for a term exceeding two years. This is an appropriate safeguard that would ensure that only sensible regulatory reform would be delivered by order. For those reasons I invite the noble Lord to withdraw his amendment.
	I believe that some time ago the noble Lord, Lord Peyton, asked what would be the effect of deleting the words "or otherwise". I assume that the noble Lord intended to ask what would be the effect of deleting the words "criminal or otherwise". If that were to happen, it would no longer be clear that non-criminal civil sanctions could be removed or reduced; in other words, a financial penalty imposed by a regulator, which is not a criminal fine. That would be the impact of the noble Lord's amendment.
	I hope that I have answered the points that were raised. If I have not, I apologise to the Committee. This has been a very constructive debate and some valuable points have been made. Nevertheless, I urge that the relevant amendments are not pressed.

Lord Peyton of Yeovil: Perhaps I should say to the noble Lord how grateful we all are to him for providing us with such a large meal in response to the amendments. Personally, I am relieved that he did not find another page in the extensive brief in front of him. I am ever so grateful to the noble Lord, Lord Borrie, who was the first to recognise that my simple and humble aim was to remove three words, "criminal or otherwise", on the grounds and in the hope that they would make no difference whatever to the sense of the Bill. Be that as it may, I would add only this: at my age, I am constantly weighed down with advice that I should keep my ambitions strictly under control. I assure your Lordships that I thought that I was doing that tonight. I am horrified to find that my humble and modest amendment has led to the expenditure of no less than 38 minutes of your Lordships' time. On that happy note, I beg leave to withdraw the amendment.

Lord Drayson: My Lords, with the leave of the House, I shall now repeat a Statement made in another place by my honourable friend the Parliamentary Under-Secretary of State for Defence and Minister for Veterans. The Statement is as follows:
	"Before I answer the honourable gentleman's question, I am sure that the whole House will join me in offering our condolences to the families of Corporal Thorpe and Lance Corporal Hashmi, the two soldiers killed on Saturday in Helmand province along with their interpreter. I have no doubt either that I speak for the House in wishing a speedy recovery to the five soldiers injured in the same attack. Our thoughts and prayers are with them all."I should also explain first, Mr Speaker, that my right honourable friend the Secretary of State has been unable to return to the House in time from his constituency, since the time that we decided to take this Urgent Question. "The losses of life that our forces have suffered over the past few weeks are a tragedy, but they do not mean that our mission in Afghanistan is somehow confused. The position of our Armed Forces in Afghanistan is clear. First and foremost, our troops are in Afghanistan to ensure that never again is it a safe haven for the likes of al-Qaeda and the Taliban. Quite simply, the risks are too great to us, our allies and the Afghan people for us to stand aside and allow the terrorists to return. That overriding aim was clear when my right honourable friend the Home Secretary announced our deployment to Helmand last January, and it is clear today."Our forces are our contribution to the expansion of the UN-authorised and NATO-led international security assistance force—ISAF. This is not just a British mission. Danish and Estonian troops are embedded into our forces in Helmand. Overall, 36 nations provide troops for ISAF. They, too, have had their casualties. A Romanian soldier was killed last month. Canadian and US troops have also died."That means that they are there to help foster the environment in which the Afghans, with the support of the wider international community, can develop sustainable governing institutions and spread the authority of central Government across the country. It means that they are there to help build up the Afghan security forces. They are there to help set the conditions for developing the Afghan economy and infrastructure. As a result of that, it means we also help put in place the sort of environment in which the Afghans, again with international support, can make an impact on the narcotics trade."Yes, our Armed Forces have been in action against the Taliban. That was only to be expected. That was why we sent an air-mobile battlegroup; it was why we sent artillery; and it was why we sent Apache attack helicopters. Let me be candid: we would not have deployed such a formidable package if we did not think that there was a real threat to the safety of our Armed Forces. It was not pulled together on a whim. We did not pick and choose. We sent what the top military advice in the country, the chiefs of staff, said that we should send. So, I want to make it absolutely clear and plain that there has never been a sense that our aims and objectives were unfocused."Of course, as with any operation, we keep our forces under review. The House will know that we regularly announce force changes for Iraq, as various formations are deployed in and out of that theatre. Afghanistan is no different. We are working through such a process now. The honourable gentleman will know that it is the intention of my right honourable friend the Secretary of State to make an announcement on the roulement of 16 Air Assault Brigade before the Recess, but he will not do so until he has received the advice of the chiefs of staff on the precise details of the roulement. That will form part of a much wider NATO process that will be under way in July."The House will understand that I cannot go into more detail now. Honourable and right honourable Members can be assured, however, that, despite press reports today, commanders have not asked for extra infantry or air cover. We do not go into this kind of thing in detail, for reasons that the House will understand, but I can go as far as to say that the latest requests to the chiefs of staff, which are part of the planned ongoing analysis, include requests for enablers and engineering equipment. I want to make it clear that these requests were expected from the outset and that, as the campaign continues, we expect more requests from theatre, and that if those do include "combat" elements, we will consider them seriously and immediately, as we always do. "I must stress, however, that we are only at the start of a three-year operation. Our forces in Helmand only reached their full operating capability this weekend. There is still much to do. We all know that the democratically elected Afghan Government have had little sway in Helmand. It is inevitable that the earliest stages of such an operation will focus heavily on helping the Afghans to create security and stability. Only then can our wider aid and development programmes go forward unimpeded. They have already begun. Once fully under way, they will in turn reinforce security and stability as Helmand's legitimate economy grows and the rule of law expands and curbs the influence of the Taliban and the drugs traffickers."I shall say one final thing: we are committed to the success of the wider international project to help to rebuild Afghanistan. We can best dothat by making a real contribution—political, developmental and military—to the stabilisation of Helmand. Our Armed Forces are doing a magnificent job in making that happen. They should continue to receive the full support of all of us in this House".
	My Lords, that concludes the Statement.

Lord Astor of Hever: My Lords, I am grateful to the Minister for repeating the Statement. We, too, send our condolences to the families of the two soldiers, and their interpreter, who were killed, and we wish a speedy recovery to the five soldiers who were injured in the attack.
	I pay tribute to all those servicemen and women serving in Afghanistan. There is no question that they will receive full support from this side of the House. The question is whether they are all receiving the full support that they are entitled to expect from the Government. The Government have two tasks: to do everything to maximise the success of the mission and to minimise the threat to our troops. But it would appear from weekend reports that both are at risk of failure.
	The Statement makes it clear that commanders have asked not for extra infantry or air cover but only for enablers and engineering equipment. But highly reliable sources on the ground have made it very clear that commanders do need more than they have got. I understand that the Minister cannot go into details, but will he specifically confirm in this House thatthe Government have received no requests from commanders on the ground or the chiefs of staff for any additional combat troops, fixed-wing aircraft or helicopters, particularly now that the army has some experience on the ground?
	Is the Minister still satisfied that we have sufficient support helicopters, particularly where casualties are involved? My understanding is that there is real concern among those serving in Afghanistan about this issue. Is there sufficient medical support in theatre?
	The Commons Defence Committee has already warned that the British force lacks sufficient air support or transport helicopters. Despite radioing for aerial support, the soldiers who managed to fight their way out of the recent ambush were apparently told that no aircraft were available.
	While it is recognised that some of our troops may be killed when engaged in a firefight with the Taliban, those troops who were killed were successfully attacked within their own base. The Statement does not recognise this. The daily attacks raise fears over the lack of air cover for vulnerable outposts. It is acceptable to send our troops to Afghanistan but it is not acceptable to have them shot at with impunity.
	As the Minister stressed, this is not just a British mission but a coalition. We welcome the fact that some of our NATO allies have made a token contribution. But what representations have the Government made with our NATO partners and European allies to ensure that they really do pull their weight? Are their combatants under the same rules of engagement as our troops?
	I accept that reconstruction and opium eradication cannot start until the security situation is more stable. When do the Government anticipate that we may be able to make a start? Senior Taliban recruiting sergeants in Pakistan have revealed how they are smuggling very large numbers of new fighters into Afghanistan, despite Pakistani Government claims that they had tightened border security. What discussions are the Government having with the Pakistan authorities about insurgents crossing from the lawless border areas of Pakistan?
	We agree with the Statement that this mission must succeed. The risk of failure is too great to this country, our allies and the Afghan people for us to stand aside and allow the terrorists to return. But the Government must give our Armed Forces the manpower and equipment to get this job done.

Lord Garden: My Lords, I, too, thank the Minister for repeating the Statement and from these Benches we offer our deepest condolences to the families of Corporal Thorpe and Lance Corporal Hashmi, and our sympathy to those who were injured and their families.
	I can be relatively brief, given that we had such an extensive debate only last Thursday, which covered many of the issues relevant to the Afghanistan operation. I have some sympathy with the military commanders who are trying to set up what is a difficult and challenging mission, which is in a process of transition from the US coalition to the NATO operation. They are getting a surfeit of advice, I suggest, from all quarters. I do not believe that it is the role of us in Westminster to try to micromanage the tactical decisions in the operational theatre. I agree with the Statement's assertion that a serious force was sent out. We recognised that at the time when there was cross-party support from us all for the operation. We recognise that it is inevitable that as the situation develops changes will be needed depending on the intelligence gathered.
	We need an assurance from Ministers that requests from commanders will be dealt with promptly and will not be resource constrained. This is a real operation that cannot operate with resource constraints. I understand that the Prime Minister has today given such an assurance. In that case, perhaps the Minister will revisit some of the questions we asked on Thursday about mobility and in particular about helicopter lift and how this new opening of the treasure chest might help things. I am happy to give him one suggestion: that he might tonight go back to his office and authorise the necessary work on the eight Chinook HC3s that have been sitting in a shed for some years now, grounded through incompetence in how they were managed before. All that is needed is money to get those helicopters flying again. How long will it take from him making the decision tonight to our getting eight more Chinooks into theatre?
	While I accept that the commanders may not at the moment be asking for more close-air support, it is clear that the current trend is for more engagements that are likely to cause difficulties in availability of close-air support. Indeed, the Sunday Times gave a graphic account of the difficulties for a unit when it is engaged by the enemy and has to wait several hours for close-air support to turn up. Will the Minister at least assure us that the Ministry of Defence is looking at options for how this might be taken forward if it looks as though we need extra forces? I am glad that the decision was made not to bring the Harriers home; that was a wise decision in the event but perhaps we need to think about how we rapidly reinforce the Harriers. In all of this, we must not forget our allies who own aircraft that could give close-air support and helicopter lift. Are we pressing them to prepare in case they are needed in future?
	I mentioned on Thursday the end of the Canberra aircraft. I was at RAF Waddington on Saturday for the farewell to the Canberra. I learnt there—I was not aware of this—of the amount of work that the Canberra PR9 has been doing in Afghanistan over the past four years. It is a unique reconnaissance capability, which will disappear on 31 July, not to be replaced. The Statement referred to enablers. The reconnaissance capability that was there was an enabler; we are losing enablers, not necessarily gaining them.
	We, too, support the aims of the Afghanistan operation. We regret that the adventure in Iraq meant that we had done too little, too late in the past four years in Afghanistan. We need to make sure that we do not make that mistake again.

Lord Craig of Radley: My Lords, I thank the Minister for his Statement. It suggests that the aims with which we set out, the force strength that we have committed and the opposition that we are currently meeting are more or less in line with the Government's anticipations. That is obviously reassuring but it has to be seen against some quite disturbing eyewitness media accounts, about which we have all been reading recently. Nevertheless, one accepts the Government's assurance.
	However, I am concerned that we are now exposed on two fronts in two different theatres against insurgents, whose performances are pretty unpredictable and can get extremely unpleasant. In either or both theatres, there will be pressure on some of the supporting elements—the helicopters, the transport and so on. Can the Minister reassure the House that there is sufficient reserve to cope with any increase in the opposition which our forces are meeting in either Iraq or Afghanistan? It would be great to know that reinforcement is available, should it be called upon. I am not asking for details but for confirmation of the general principle that the need for reinforcement could be met if required.

Earl Attlee: My Lords, I am grateful to the Minister for repeating the Statement. I remind the House of my peripheral interest. The casualties are, of course, extremely regrettable. Sadly, we know full well that they will not be the last, but it is our duty to provide full moral support.
	During a recent Oral Question, I asked about the funding for the operation in Afghanistan. The Minister pointed, I think, to £1 billion of funding, but presumably that includes the DfID funding for the provincial reconstruction teams that we hope will do such an important task. No doubt there is much, quite carefully targeted work being done, which is very welcome. Is the military side of the operation funded from the MoD main budget as an enduring operation, or is the operation funded on the same basis as OPTELIC 1? In other words, is the operation an enduring one, funded by the MoD, or an additional one, in which the marginal or avoidable costs are funded from central Government? That is important because the top military advice in the country, referred to by the Minister, was given in the context of a funding envelope, as was the planning.
	In another Oral Question, my noble friend Lord Astor of Hever asked about helicopters. The Minister stressed the importance of managing the helicopter flying hours. Does that mean that commanders in the field are being rationed on helicopter flying hours, even if it is necessary to avoid breaching logistic limits rather than financial ones? It is fine for the Prime Minister to talk about extra resources being provided if necessary, but no one can do anything about a physical limit.
	My noble and learned friend Lord Mayhew asked about the rules of engagement, and the Minister gave absolutely the right answer. The only point to note is that our opponents in these sorts of operations always know exactly what our rules of engagement are. The only people who do not know are Members of Parliament.
	The Minister says that necessary manpower resources would be provided if necessary. It is important to remember that, if we wanted to deploy another brigade, we could not. We do not have another brigade. Part of the reason for that is the Bowmanisation project, now on track, which unfortunately takes out a whole brigade, so we currently have extremely limited manpower.

Baroness Thomas of Walliswood: rose to ask Her Majesty's Government, in the light of the report of the European Union Committee on Paediatric Medicines: Proposed EU Regulation (20th Report, HL Paper 101), what steps they are taking to ensure that the proposed European Union regulation on medicinal products for paediatric use will meet satisfactory ethical standards on implementation, that the incentives proposed will be effective, equitable and proportionate and that the working of the regulation will be rigorously reviewed.
	My Lords, we are here to discuss our recent report on paediatric medicine. The Commission's proposal for regulating medicinal products for paediatric use reached Sub-Committee G in December 2004, and by the summer of 2005 it was clear that the UK Government wanted to achieve the approval of the document by the end of the UK presidency.
	The main elements of the proposal were, first, a package of rewards and incentives to encourage the pharmaceutical industry to test products for use in children across the European Union and to develop and/or adapt them to paediatric use. Secondly, the European Medicines Agency would appoint an expert paediatric committee to oversee and assess paediatric investigation plans for developing medicinal products for children. Thirdly, a European clinical trials network would be set up to foster communication and collaboration on paediatric studies throughout the EU. Fourthly, authorisation procedures would be based on the Community's clinical trials directive and details of paediatric trials would be entered on the European clinical trials database. Medicines tested for paediatric use would be sold with a special label indicating that fact.
	Sub-Committee G appreciated the potential value of encouraging the clinical testing of medicines for paediatric use across the EU market. However, there were ethical and practical concerns and a decision was taken to undertake a brief inquiry. We received a wide range of evidence from interested parties including, most helpfully, from Professor Sir Cyril Chantler, the chairman of the Great Ormond Street Trust. We also saw the results of the consultation carried out by the Healthcare Products Regulatory Agency. We also had a good deal of correspondence and a very useful evidence session with the then Minister of State at the Department of Health, the right honourable Jane Kennedy MP and her officials.
	As our report shows, we were convinced that there was a real and urgent need for this regulation. More than half of all the medicines currently given to children and 90 per cent of those given to newborn babies have never been tested for that use. Furthermore, not only can the results of tests of medicines in adults not be extrapolated reliably for their use in children, but children can react very differently to drugs according to their age, among other factors. Many drugs are formulated in a way that does not suit children, in particular, very young children. Moreover, the pharmaceutical industry can find it relatively unrewarding to do the necessary but expensive research needed to produce or adapt medicines for children's use because the market is relatively small and complicated. Meanwhile attempts by member states to encourage them to do so have not been successful.
	But we concluded that the proposed package of rewards and incentives, although based on a successful scheme in the United States, was something of a leap in the dark. Under the scheme, pharmaceutical companies can expect an extension of the sole right of sale of their product if they do the research required to prove the product's efficacy in treating children. But we could not judge with confidence whether the proposed regulation would have the desired result, whether the manufacturers would be insufficiently, reasonably or even excessively rewarded and what the effect on health service budgets would be. We also understood that some member states opposed any delay in the release of medicinal products to the generic manufacturers, who are significant players in new member states in eastern Europe.
	As the December 2005 Council meeting approached, it was clear that member states were ready to approve the proposal. We were aware of the weight of professional opinion in this country that the proposal should be implemented as soon as possible. We concluded that it would not be sensible to stand in the way of such an agreement and, exceptionally, agreed to lift scrutiny in advance of publication of the report. Political agreement was secured by the UK presidency at that Council meeting.
	Two issues still concerned the committee. The first was whether the guidelines for the detailed application of the regulation really would take on members' concerns about the consent of minors, the rights of children and their parents, the proper publication of all the research projects in a transparent way and product information and labelling. The second was the legal base for the new regulation. On the matter of guidelines, we had been partially reassured by meeting the officials dealing with the details under comitology procedure. They clearly understood the committee's concerns and assured us that these matters were being pursued by them in committee. It was also agreed by the Minister that, as a condition of lifting scrutiny, officials would brief Sub-Committee G on the development of the guidelines once the regulation was adopted and that the Government would hold the Commission to its commitments to give a full review of the working of the regulation and on access to the database. The Minister further agreed that when the operation of the regulation came under review—which might be in six or 10 years' time—our successors would be briefed on the practical operation of the guidelines. I hope the Minister can confirm tonight that that approach still reflects the Government's intentions.
	I now turn to the matter of legal base, which is always of importance to the Select Committee. There was some concern that the Government, despite their judgment that the proposed legal base—Article 95 of the EC Treaty—was not appropriate, were preparing to give political consent to the regulation so long as they lodged a minute statement officially recording their objection. We understand that that was done and that several relevant rulings have since been given by the ECJ. Can the Minister bring us up to date on this matter?
	After the report had been published, a final and unexpected coda to our deliberations was provided by the representations from the Association of the British Pharmaceutical Industry to the effect that the amount of time allowed for companies to make application for the right to conduct tests was insufficient, particularly in the years immediately following implementation of the regulation. We understand that a European Parliament common position to that effect was adopted on June 1. We also understand that the Government endorse that position, and it would be helpful if the Minister could explain the latest position.
	I have tried to give an overview of our report. I am confident that other members of the sub-committee will be able to fill out many of the details. It was a piece of work to which every member brought real personal commitment and knowledge. I am delighted that this debate has attracted speakers who were not members of the committee. I cannot close without thanking the committee secretary, Gordon Baker, and his staff for all their support. As Mr Baker may have to leave us before another of these occasions occurs, I should put on record our very real appreciation of his hard work, cheerful disposition and impressive drafting skills that have been of such immense service to the committee and to all its members.

Lord Turnberg: My Lords, I congratulate the noble Baroness, Lady Thomas of Walliswood, and her committee on a thorough, commendable and—dare I say?—readable report. I also congratulate her on her excellent introduction.
	I find it remarkable that although we go through such an elaborate and robust system of testing drugs before they are used in adults, many drugs given to children have not been tested in children at all. Before a new drug can be given to an adult, it has to go through several phases of trials to assess its safety and efficacy in treating the disease for which it is prescribed. However, the practice in children, more often than not, has simply been to scale down the adult dose according to weight and age on the basis that a child is just a small adult and ignoring the fact that a child's metabolism may be quite different from that of an adult. The reason for that is that very few drugs have been tested in children, so unfortunate paediatricians have to rely on their experience and prescribe off licence or not prescribe at all. Every day, paediatricians face the dilemma of whether it is more unethical to prescribe a drug that has not been tested or to deny treatment to a sick child. They do not have the comprehensive information on risks and benefits that would allow them to make an informed judgment. For example, 90 per cent of drugs used in the very emotive group of patients—the neonatal babies in intensive care—are unlicensed or off-label medicines. Therefore, the new EU regulations that are designed to encourage the testing of drugs in children are welcome. Indeed, they are essential.
	The regulations follow fairly closely changes introduced in the United States that were shown to be effective in increasing the number of drugs tested. I understand that some 30,000 children in the US have been entered in clinical trials. This is an extremely sensitive area because no parent wishes to see his child used as a guinea pig, but if that idea is followed through to its logical conclusion, every child becomes a guinea pig if the drugs have not been tested properly. It can be argued that not to do proper studies in children is unethical. The answer lies in sensitive and carefully managed systems of consent and extreme care with safety issues, which are covered by ethics committees. The evidence is that these issues can be fully taken into account with due care. One study by the National Perinatal Epidemiology Unit in Oxford retrospectively questioned 100 parents of neonatal babies who had been in a controlled trial of extra-corporeal membrane oxygenation. They were asked whether they had had any qualms about their babies being involved in the trial and none said that they regretted it, even though some babies in this group of extremely ill neonates had died. So it can be done, and with carefully conducted controlled trials it is now possible to treat so many forms of childhood leukaemia so well and new ways of treating childhood asthma have become possible. So I am sure that the new EU regulation, which offers some important inducements to the pharmaceutical industry, will be well received. Although it may be a great leap of faith, we have the evidence of some success, at least, from the American experience.
	Paediatricians are now well set up to undertake trials in the UK with children in a sensitive and highly ethical way. The guidelines from the Royal College of Paediatrics and Child Health, which have been helpfully appended to the report, give some confidence. They describe how it is possible to obtain consent from a child who is able to give consent, and recommends that that should be the normal course, and only if the child is unable to give consent—too young—should parental consent triumph.
	It will be important for government guidelines to be constructed in such a way as to give reassurance to parents and children as well as to paediatricians, and that they ensure full transparency. They should also encourage rapid and wide dissemination of results so that drugs which are shown to be of value can be used as soon as possible, and those that are not can be avoided.
	Finally, this regulation is welcomed by paediatricians and I hope that the Government will move quickly so that it can be adopted.

Lord Colwyn: My Lords, I thank the noble Baroness, Lady Thomas, for her chairmanship of the committee and the way she introduced the debate this evening, Gordon Baker for his advice and guidance, and Sir Cyril Chantler for his expert opinions. The problem of funding complete trials of adult medicines used for children means that thousands are being prescribed "off-label" therapies that have not been licensed for such use.
	Paediatricians and paediatric pharmacists are faced with the difficulty of prescribing and supplying medicines for children without the support of clinical trial evidence, which is available for adult medicines from the specification of product characteristics supplied by the manufacturer.
	At least one unlicensed or off-label drug is received by 11 per cent of children treated at home by their GP, 67 per cent of children in hospitals across Europe,70 per cent of children in paediatric intensive care and, as we have heard from the noble Lord, Lord Turnberg, 90 per cent of babies in neonatal intensive care.
	A study by the University of Liverpool found that 6 per cent of children had suffered adverse reactions to an off-label medicine, and French research has suggested that the risk of serious side effects is up to three times higher.
	The use of off-label and unlicensed drugs to treat children is widespread and occurs in medical and surgical wards as well as with critically ill children. Off-label use occurs more frequently—drugs are being used in children at ages for which they have not been licensed and evaluated—at doses greater than that recommended by the manufacturers and for indications outside the terms of the product licence.
	The committee's conclusion is that there is an overwhelming and urgent need to take effective action at European level to govern clinical trials in children and the authorisation of medicinal products for paediatric use with the minimum delay.
	The EU regulation recognises that paediatric licensing is essential for all categories of medicines for children. This includes new medicines yet to be authorised, existing medicines under patent protection and those where patent protection has expired. It attempts to use both obligation and incentives and rewards to achieve this.
	Children are subject to many of the same diseases as adults and, as would be expected, are treated with the same drugs. The absence of paediatric testing and labelling causes significant risks for children. Inadequate dosing information exposes them to adverse reactions that could be avoided if such information were provided in product labelling. The absence of paediatric testing and labelling may also expose children to ineffective treatment through under-dosing or may deny them the benefit of therapeutic advances because physicians choose to prescribe existing, less effective medication because of insufficient paediatric information about a new medication.
	The medical community has shown increased concern about the lack of information for over 20 years. My own experience within a dental environment has shown me that different drugs work in different ways at different ages. Children are defined as "someone under 19". It seems obvious to me that the pharmaceutical companies should ideally provide information about how drugs work in several stages of childhood. A drug will have a variable effect on a neonate, a new born infant, a one to four year-old, a four to 10 year-old, a 10 to 13 year-old and a 13 to 19 year-old, but they are all classified as "children".
	It is difficult enough for pharmaceutical companies to undertake adequate phased testing of drugs for adults. To have to evaluate a medicine for the six additional categories that I have listed would take many years and bear a disproportionate cost, perhaps even making it impracticable to consider the use of the drug for children.
	The impact assessment of the proposed EU regulation estimated that to deal with the increased number of applications, the EMEA budget would have to be increased by between 67 to 150 per cent, or €130 million to €195 million, the cost to the pharmaceutical industry being about €4 million per product.
	It is proposed that medicines and products covered by existing patents, or granted market exclusivity by supplementary protection certificates under existing EMEA authorisation procedures, shall be entitled to a six-month extension of the market exclusivity and an additional two years' market exclusivity to which orphan medicinal products are entitled under existing EMEA authorisation procedures, making 12 years in all.
	Ten years of data protection for new paediatric studies would also be granted to off-patent medicinal products developed specifically for use in children. Products developed under this provision would be granted Paediatric Use Marketing Authorisation. Historically, this has been successful in the USA, which introduced the "paediatric rule" and the "paediatric exclusivity" provisions, adopted in 1998 and 1997 respectively. This legislation provides six months' exclusivity in return for conducting paediatric studies and has been highly effective in generating paediatric studies on many drugs and in providing useful new information in product labelling.
	Some categories of drugs and some age groups remain inadequately studied despite these new incentives, but suggestions have been made for modifications to the paediatric exclusivity provision that may address these gaps.
	For some products and for some age groups the incentives provided have not produced proposals to conduct paediatric studies. The incentive is not adequate for old antibiotics and other drugs lacking market exclusivity or patent protection because these products are not eligible for any exclusivity under the current paediatric exclusivity provision.
	While the incentive provided by paediatric exclusivity provision has been adequate for many products, it has naturally tended to produce paediatric studies on those products where the exclusivity has the greatest value, and not on those which no longer have patent protection or exclusivity, or small markets.
	My time is up. Manufacturers should be encouraged with further incentives to study those drugs that provide the greatest health benefit to children, including those that are not eligible for incentives in the current situation. I hope our report will influence further consideration of this situation.

Baroness Howarth of Breckland: My Lords, as a member of the sub-committee, I add my tributes to the noble Baroness, Lady Thomas, and Gordon Baker. I am always totally amazed how even my modest comments can be turned into erudite recommendations. I have particular declared interests in children and health and I must say that the work on the report gave me equal proportions of satisfaction and dismay. I had satisfaction that, at last, paediatric medicines are being addressed, but dismay that, having reached the 21st century, there is still so far to go, although I am encouraged by the contribution of the noble Lord, Lord Turnberg, who seems to think that at least something is moving forward.
	We have heard several times that children are not small adults. We heard from the excellent evidence of Sir Cyril Chantler that there are two major problems with the use of unlicensed medicines: how children's metabolism deals with the drug, and the effect on the child. The European Commission stated that 50 per cent to 90 per cent of all medicinal products used in the paediatric population have never been studied or authorised for use. Consequently, among the long list of problems outlined by Sir Cyril and well known to those dealing with children is the control of pain. Were the situations where children suffer to happen to adults, they would simply not be accepted. There would be a major campaign. We hope that our report will help the Government to take forward this important issue of paediatric medicine.
	As with all pharmaceuticals, the need for rewards and incentives is a major driver. The noble Baroness, Lady Thomas, and the noble Lord, Lord Colwyn, have both outlined the issues; the noble Lord, Lord Colwyn, did so in detail. It is therefore enough for me to observe that it appears that, without the intervention of this directive, children's medicines will be developed by market forces rather than any altruism or proper concern for our most precious asset: our children. That is why the directive is vital.
	There is a similar issue with research where, under the directive, the European Medicines Agency will oversee and co-ordinate the tasks envisaged by the proposed directive, but the Royal College of General Practitioners questioned whether it would be best placed to provide the proposed scientific advice, which would be a significant undertaking. Unfortunately, the sub-committee was unable to judge from the evidence that we received whether the proposed funding framework would be adequate. What progress has been made in that area and on the need for a separate Community-funded programme of research?
	The sub-committee was much exercised about the ethical considerations of consent. Although agreeing that the health and welfare of children must be the overriding priority for conducting paediatric trials, in her evidence the Minister drew a distinction between what she described as a properly informed decision and one that might be no more than what she called a whim.
	We were troubled by that issue. I add my concern that children are consulted appropriately by those who understand how to communicate with them, not by those who have a vested interest in getting a particular answer. Anything that the Government can do to progress that would be most welcome.
	In the short time available, I also mention labelling—a topic on which I spent much time as a member of the board of the Food Standards Agency. It is equally important that we get that right for children's medicine. We hope that the Government will be active at EU level and in the UK to ensure that products are labelled in a way that indicates their suitability for children, taking into account their size and development, and in a way that parents can understand and is distinctive.
	If we get all that on track, it will be of little use if the Government do not get right the services for specialist paediatric groups—those services in which the medicines will be used. Stepping outside the brief of the sub-committee, I take this opportunity to urge the Government to speed up their major review of cardiac surgery for specialist care. I know that the Government have started that but, although Scotland, Wales and Ireland have already moved to a high level of care for all, rather than a postcode lottery, we in England still have no clear plan for central funding and standards.
	I realise that the Minister may not be able to answer that point this evening; if he is not, could he write to me to explain how the proposed working party is progressing? Paediatric medicines will then have a proper context for progress.

Baroness Neuberger: My Lords, I, too, thank my noble friend Lady Thomas for chairing the inquiry, and our remarkable Clerk, Gordon Baker, for his superb drafting of the report.
	It is undoubtedly worth saying how wide the support has been generally for the regulation. Broadly speaking, the medical profession and others have really wanted it, as the noble Lord, Lord Turnberg, has made clear. As we have also heard, however, several issues concerned us. My noble friend Lady Thomas alluded to the fact that drugs are not tested on children, as did the noble Lord, Lord Colwyn, who commented that the pharmaceutical industry does not find it worthwhile to do some of the research. The noble Lords, Lord Turnberg and Lord Colwyn, both spoke about the ethics of prescribing and providing drugs for children that were not tested on children. There were also concerns about further incentives for the pharmaceutical companies and general issues around testing on children, and we have just heard the comments of the noble Lord, Lord Trefgarne, who is very worried about children being able to give consent. Perhaps the issue of children's consent is the one that troubled us the most, as the noble Baroness, Lady Howarth, has said. It certainly troubled me the most.
	The clinical trials directive requires that a person with parental responsibility, or a legal representative, must give informed consent to any trial involving a minor, whereas the explicit wish of a minor to refuse to participate or to be withdrawn from clinical trials "must be considered". A clinical trial has to be designed to minimise pain and discomfort, fear and other foreseeable risks in relation to the disease and the developmental stage of the child concerned. We drew the attention of Professor Chantler, the chairman of Great Ormond Street Hospital, who gave evidence to us, to that statement. He was very firm about this. He argued, contrary to the view of the noble Lord, Lord Trefgarne, that,
	"one would be surprised how it is possible to find out what is in the child's interest from the child's point of view in very young children: you just have to find more imaginative ways of communicating with them. The notion that you would do something to a child that did not involve the child's consent is not acceptable".
	He continued—I do believe it is worth quoting:
	"Obviously there are occasions, I know, where doctors and nurses have to do things and the child does not want them done and the child may cry, but you pay a terrible price for that. I constantly as a paediatrician was upset by people saying to children, 'This isn't going to hurt.' Of course it is going to hurt. Once you say it is not going to hurt and then stick a needle in them and they cry, two things have happened: one is the child has suffered pain which you might have been able to find a way of avoiding—and we are better at that now—but, perhaps more importantly, you have lost that child's trust forever. It is a very serious matter to do something to a child that does not have the child's consent. Participation in a trial, I think, would require the child's consent as well as the family's".
	Professor Chantler thinks that the guidance will need to be strong enough. We do not yet have that guidance. We await the guidelines and, like my noble friend Lady Thomas, we very much hope that the Government will watch this closely and ensure that the guidelines make it explicit that the child's wishes have to be more than taken into account; they have to be recognised. But it is a complicated issue. We still live in a society where children's views are often insufficiently taken into account. The first work—20 years ago—by Richard Nicholson showed that, in research ethics committees looking at research on children, consent was less likely to be given to research on children if a nurse was present, regardless of whether she spoke. It suggested that there were various people around who were quite prepared to carry on doing things that some of us now might not find acceptable. Children have views, so we have to clarify the extent to which the child's view is to be taken into account.
	When the Minister came to speak to us, she was not worried that the child's views must be considered, but wanted to draw a distinction between a properly informed decision by a child and one that might be no more than a "whim" on the day concerned. The noble Baroness, Lady Howarth, has already drawn our attention to that. There are two problems with it. The first is that adults are allowed to be subject to whims or fancies in consent to research; and so one has to ask why children should not be. Secondly, there is a real problem, on which Priscilla Alderson has been the great expert, about consent from children. What if the child has just had enough? Children who are very sick sometimes express the view that they have just had enough and want no more done.
	We were much reassured by Sir Cyril Chantler and by the Minister's assurances to us. However, until we see the regulations and guidance, and until we know that the database on research in children will be freely available, we cannot rest completely. Children's interests must be taken into account. I hope that the Minister will be able to give us the Government's reassurance on this matter.

Lord Warner: My Lords, noble Lords will be pleased to know that I am not going to speak for 20 minutes; even I recognise that you can have too much of a good thing. I am pleased to have the opportunity to set out the Government's views on the new European regulation on medicinal products for paediatric use which comes into force later this year. I am grateful, as are other noble Lords, to the noble Baroness, Lady Thomas of Walliswood, for her sub-committee's report and the opportunity she has provided for noble Lords to discuss this important issue. I certainly have a personal interest in the subject; it is one I have had for some time.
	I should like to make it clear at the outset that the Government have been supportive of legislation in this area for a number of years and welcome the efforts made by the Commission to progress this regulation. It was a key priority during the UK presidency last year and I am pleased that political agreement was achieved during our presidency. The Government have been concerned for many years about the lack of medicines authorised and formulated specifically for paediatric use for the reasons mentioned by a number of noble Lords this evening. Because of our concerns, we took steps at the national level within the existing regulatory framework: first, to produce in the short to medium term an increase in appropriately labelled and formulated medicines for children; and, secondly, to increase information on the paediatric use of medicines for prescribers, carers and patients through the children's British National Formulary. I should add that this is probably one of the most useful things I have done as a Minister. There may not have been many of them, but the BNF was one of them. Thirdly, we have ensured that appropriate standards are met for the conduct of clinical trials of medicines involving children.
	However, the Government have always considered that a pan-European legislative solution was required to address the current situation. The regulation responds positively to concerns expressed by all member states, including the UK. We were not alone in wanting to address this issue. We recognised the need for a regulatory approach that includes both incentives and requirements to ensure that new medicines along with medicines already on the market meet the specific needs of the paediatric population while also ensuring that children are not subjectedto unnecessary clinical trials or delaying the authorisation of medicines for adults. That second issue has been around for some time and has had to be addressed and dealt with. I am very pleased to report that a Second Reading agreement was reached on the regulation in the European Parliament on 1 June 2006. This means that the regulation will come into force later this year.
	One important outcome of the regulation—indeed, one of its objectives—will be an increase in the number of clinical trials in children. Some people, understandably, have expressed concerns about involving children in clinical trials. But let us be clear: if a medicine is to be used in children, the only way of determining whether it will be beneficial and safe is by conducting clinical trials in children, as my noble friend Lord Turnberg so clearly expounded. These trials in children will make an important contribution to public health by providing the scientific base for authorising new essential medicines, particularly for inadequately treated diseases. Equally important, the trials will provide information on when not to use medicines in children, and why.
	In recognition of the importance of clinical trials in children, the Government launched the Medicines for Children Research Network last year to provide a world-class health service infrastructure to support high-quality trials of medicines for children. We want to do this job well and that is why we have involved the experts in this network.
	A number of noble Lords have raised issues around the ethical considerations. Involving children in clinical trials clearly raises a number of ethical issues. I should like to emphasise that the Government attach the greatest importance to ethical standards, an area which I know is of particular interest to the House not only in this debate but more generally. The rules governing the conduct of clinical trials are both detailed and specific. The paediatric regulation contains a range of measures specifically to safeguard those participating in paediatric clinical trials. These are over and above the high standards introduced by the clinical trials directive to protect minors. The directive requires that ethical and procedural criteria specific to children are in place before entering them into a trial.
	The Government believe that the protection of those participating in clinical trials must be the overriding priority and believe that the safeguards laid down in the clinical trials directive and the measures in the new regulation provide a secure framework to ensure that the health, welfare and rights of children participating in clinical trials are protected. I reassure the noble Lord, Lord Trefgarne, that the clinical trial on a minor may be undertaken only if—and I give one example—the informed consent of the parents or legal representative has been obtained. Consent must represent the minor's presumed will and may be revoked at any time without detriment to the minor. The explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator. That is already provided for. I rather share the views quoted bythe noble Baroness, Lady Neuberger, of Cyril Chantler—to whom a number of noble Lords have paid tribute today and who has probably seen more children undergoing great suffering than any of us. I rather share his view that with appropriate creativity and patience we can secure informed consent from many more children than has often been the case. Certainly the clinical trials directive does nothing—quite the opposite—to ensure that we work hard at securing children's consent in these often very difficult sets of circumstances.
	Perhaps I may reassure the House that, in addition, the European Commission, in consultation with member states, is preparing a guideline on the ethics of conducting clinical trials in children. The commission intends to publish the draft guidance in the autumn for consultation before it is finalised and in place when the new regulation on medicines for paediatric use comes into force.
	This guideline, along with others that are being developed, will be important in setting out how the regulation will work in practice. I will mention the other guidelines later, but I can reassure the House unequivocally that the Government would not have supported a proposal with implications for conducting clinical trials in children if we were not absolutely convinced from all the expert advice we have received that this was the right thing to do.
	A number of noble Lords mentioned incentives. The proposed incentives under the regulation stimulated much debate in Europe, but most people accept that incentives are necessary. The Government carefully considered the implications of the proposed incentives and agree that it is important to provide fair incentives to the research-based pharmaceutical industry to stimulate the necessary research. It was clear from the range in the commission's impact assessment of the regulation and the Government's partial regulatory impact assessment that it was not possible accurately to estimate the impact on the NHS at the present time. Because of this uncertainty, the Government felt it was important to make the case for a robust review of the economic and health benefits of the regulation, and this was agreed.
	The European Commission will provide a general report within six years of the regulation entering into force. That will include a detailed inventory of all medicinal products authorised for paediatric use under the regulation and, if sufficient data have accrued, the commission will provide a report on the economic impact of the rewards and incentives along with an analysis of the estimated consequences for public health. If the data are insufficient to allow a robust economic and public health impact assessment at this stage there is the possibility of conducting a further review within 10 years of the regulation entering into force.
	I can assure the House that the Department of Health will monitor the impact of the incentives. As set out in our response to the scrutiny committee's report, we will also update the regulatory impact assessment once the data are available, and make this information available to the Committee. I can certainly give the noble Baroness, Lady Thomas, the reassurance that she was seeking. I can also reassure her that we now accept that Article 95 of the treaty is an appropriate legal basis for the regulation.
	As I mentioned earlier, specific guidance will be developed to underpin the regulation in a number of areas including, for example, the rules of procedure for the paediatric committee and guidance on the required format and content of an application for agreement of a paediatric investigation plan. The European Commission will have responsibility for developing the guidelines in consultation with the member states. Let me reassure my noble friend Lord Turnberg that the Government will ensure that all stakeholders, including healthcare professionals, parents, patient organisations and the pharmaceutical industry are able to provide input at the appropriate stages.
	The UK led the development of European guidance on the conduct of pharmacovigilance in children. This was recently finalised following a period of public consultation and underpins the strengthened requirements for paediatric pharmacovigilance which are set out in the regulation and will reinforce the use of medicines in children.
	The House will be aware of the extensive consultation on the regulation that was conducted by the European Commission, the Department of Health and the MHRA—the Medicines and Healthcare products Regulatory Agency. Consultation responses, including those from paediatricians and other healthcare professionals, indicated strong support for the new legislative framework. The Select Committee's own inquiry and report on the regulation welcomed the proposed legislative framework. I cannot answer the question of the noble Baroness, Lady Howarth, on the cardiac working party, but I will certainly write to her.
	In conclusion, I believe the proposal strikes the right balance between protecting public health through the development of properly tested and formulated medicines for children and assuring high-quality paediatric clinical trials in the UK. The proposal is long awaited, and we are pleased that the new regulation will become a reality in the very near future.

Lord Goodhart: I entirely agree with the noble Lord, Lord Jenkin, that the Sale of Goods Act 1893 is a masterpiece of parliamentary draftsmanship. There was a golden period of parliamentary draftsmanship, which ran roughly from about the late 1880s until the First World War, when the parliamentary draftsman were brilliant at producing quite simple, easily understandable Bills, dealing with issues like the sale of goods and the Partnership Act 1890, which was extremely clear and, effectively, lasted for over a century.
	To get a bit closer to business, I must say that I was grateful to the noble Lord, Lord Kingsland, for his support of my amendment. I return the compliment by expressing support for his.
	We are ending up in a thoroughly untidy situation here. It is increasingly clear that Clause 1(5) and subsections (3) and (5) of Clause 4 are themselves hard to understand. If they go into the Act, as it will become, they may well be prime targets for the necessary orders.
	The position on consolidation is extremely complex. We all agree that consolidation enormously helps lawyers and lay people to understand what the law is. We have a situation where, if it is pure consolidation, you must have a consolidation Bill because the definition of "restatement" makes it clear that you cannot restate legislation unless it does more than merely restating it. If you are consolidating with a few changes, you can use a restatement procedure. You cannot consolidate with more substantial changes because you are doing something more than restating the law. We are getting into a great state of confusion.
	There are undoubtedly serious problems with the provisions that this group of amendments looks at. I intend to take this away, and I expect that we shall come back; not necessarily with Amendment No. 17 in its present form, although I would not rule that out. Alternatively, we will come back with something else, taking into account the nature of tonight's debate. Meanwhile, I beg leave to withdraw the amendment.

Lord Maclennan of Rogart: While I have considerable sympathy with what I take to be the purpose of this amendment, I do not think it has solved the conundrum to which the noble Lord, Lord Jenkin, referred. The amendment does not effectively impose any enforceable obligation to act. It requires the Minister to,
	"lay an order within no more than three months"
	but does not tie that obligation to any period in time. It would be open to the Minister to say that he had not observed any difficulty or burden and thus avoid the obligation. It is helpful to have identified the problem, but we need to consider this further.

Lord Bassam of Brighton: This is a complex group of amendments, including both government and opposition amendments. For that reason, I think that I had best address our amendments and then work at some pace through the others in the group. Amendments Nos. 65 and 66 and 68 and 69 concern the power to confer legislativefunctions by order. The ability to confer the function of legislating is important so that orders can be more easily designed to deliver large-scale reforms to entire regimes.
	A function of legislating, as the Bill specifies, means to legislate by order, rules, regulations or other subordinate instrument. Bills of an equivalent size often include powers to make secondary legislation, since it is usually not appropriate or necessary for all the detail of a statutory regime to be set out in primary legislation, or because some aspects of a statutory regime may need subsequent amending or updating.
	We welcome the conclusions of the Delegated Powers and Regulatory Reform Committee, which stated that including in the Bill a power to confer legislative functions by order to Ministers and other suitable bodies is not inappropriate. The committee evidently has a lot of expertise in this area and we are very grateful for its support.
	Amendment No. 65 restricts the persons or bodies eligible for such powers to three categories. The first is Ministers—the category of persons most likely to be given powers to legislate as part of future orders. The second category is persons or bodies who have functions under an enactment. That will ensure that powers to legislate will be conferred only on persons or bodies already recognised by Parliament as suitable. The third category is a body, or the holder of an office, which has been created by the order itself. That power will be useful, for example, in the case of mergers, where the successful transfer of function may necessitate the creation of a new body.
	A minor amendment, Amendment No. 66, has been proposed by the Government to further clarify the parliamentary procedures that must apply to the exercise of legislative powers conferred on Ministers. We hope that that minor power will be seen as useful and valuable.
	We have also sought under Amendment No. 65 to respond to concerns surrounding the ability of bodies or officers who have been given legislative power by order further to delegate those powers to others. Evidently, that would be an inappropriate use of the power in the Bill and is something that the Government want to protect against. I have already stated that the Government's view is that it would not be possible further to delegate legislative powers conferred by order under the Bill; an express provision in the Bill would be needed in order to allow that. However, to put the issue beyond doubt, Amendment No. 65 explicitly prevents powers to legislate conferred by order being further delegated to someone else.
	The purpose of government Amendments Nos. 20 and 36 to 38 is to make clearer the types of provision that it is possible to make under Clauses 1 and 2. In general, they are drafting improvements which are not intended to change the scope of those powers. Amendment No. 20 re-organises and makes minor changes to some of the provisions in Clause 1(7) and in doing so makes it clearer that orders made under Clause 1 may contain provision abolishing, conferring, or providing for the delegation of functions of any description, and that they may create new bodies or offices.
	Amendments Nos. 36 to 38 similarly improve Clause 2 to make it clearer what can and cannot be done under the power. In particular, the amendments make it explicit that an order under Clause 2 cannot create or abolish any new regulatory function. Clause 2 is about affecting the way in which regulatory functions are exercised, and not about changing those functions. The amendments clarify that it will be possible to create or abolish bodies only in the context of transferring regulatory functions to new bodies, and only then for the purpose of furthering the principles of better regulation set out in subsection (3).
	Amendments Nos. 68, 69, 86, 87 and 90 introduce minor drafting changes or consequential amendments to Clauses 5 and 15, and are considered necessary for the purposes of clarity. Amendment No. 68, for example, is purely consequential on Clause 5, which now contains an extra subsection. Amendment No. 69 simply moves the definition of "a function of legislating" from its previous position in Clause 22, as it is better placed in Clause 5. Amendment No. 90 ensures that this definition also applies to Clause 15. For these reasons, I commend the amendments to the House.
	I would rather address the other amendments in the group when I have heard the range of arguments from noble Lords opposite. I think that will probably be more helpful to your Lordships' House. I beg to move.

Lord Norton of Louth: My Amendment No. 25in this group was prompted by the report fromthe Delegated Powers and Regulatory Reform Committee. It conceded that it did not regard sub-delegation as inappropriate, but at paragraph 35 it argued,
	"that the bill should specify the categories of person ...who, in addition to Ministers, could by order be empowered to legislate".
	My amendment was designed to address that. To some extent, it is now superseded by government Amendment No. 65, but my amendment would limit it to new subsection (A1)(a) and (b). I share my noble friend's concern about the inclusion of paragraph (c), which extends it to,
	"a body which, or the holder of an office which, is created by the order".
	To some extent that seems to get around the provision that we are seeking to limit. It seems almost to negate the purpose of bringing this provision forward. While I welcome the move forward that this represents in responding to the report of the Delegate Powers Committee, it would be better if subsection (A1)(c) was not included.

Lord Jenkin of Roding: I have anxieties about one of the government amendments, Amendment No. 38 which, as the Minister described it, refers to the ability,
	"to create a new body to which, or a new office to the holder of which, regulatory functions are transferred ... to abolish a body from which",
	et cetera. I shall give an example. When we were debating the Human Tissue Bill a couple of years ago, which resulted in the creation of the Human Tissue Authority—certainly a regulatory body with powers to make regulations—it came out almost by accident that in the Government's cull of non-departmental public bodies, the department had it in mind to merge the roles of the Human Tissue Authority with the Human Fertilisation and Embryology Authority. The result in the Committee—I do not think the patronage secretary was there at the time—was that the very experienced and knowledgeable medical Members who sit in many parts of this House were immediately alerted and outraged. They said—and I joined in the debate because, as a former Secretary of State for Health, perhaps I had some standing—that these were two entirely different bodies and it would be absurd to merge their functions into a single body.
	The Minister in charge of the Bill, the noble Lord, Lord Warner, was immediately aware that he had trodden on a snake in the long grass and hastened to assure the Committee that no such merger could possibly take place without primary legislation. So we subsided and said that that would be an opportunity to lay to rest what was seen by many of us as an absurd proposal. One has only to think for a moment to realise that they are two entirely different bodies with entirely different functions.
	After reading government Amendment No. 38, and in particular subsection (4A)(a) and (b), it seems to me clear beyond peradventure that, if it goes into the Bill in this form, the Government could achieve their aim of merging those two regulatory bodies into one by transferring the functions of both to a new body and then abolishing the old ones. I do not expect the Minister to be fully au fait with the intricacies of what was discussed in the Human Tissue Bill—now the Human Tissue Act—but it is a concrete example of what appears to be the possibility that is opened under this new clause and that ought not to be opened at all.
	I hope the Minister will be able to give us some reassuring words that he will be able to consult with his colleagues and say, "Of course, this will not happen". If necessary, we can look for amendments at a later stage which would make it perfectly clear that that, or anything like it, would require primary legislation and could not be achieved by an order under this Bill.

Lord Bassam of Brighton: I am grateful to noble Lords for their contributions to the debate on the further group of amendments and for their points on the amendments that I moved earlier. I intend to take the groups of amendments in order and deal with the points that have been raised. I am grateful, too, to the noble Lord, Lord Maclennan, for his constructive comments on the government amendments. In his comments and commentary he raised some valuable and valid points about process and I shall make one or two observations about that.
	Perhaps I may deal first with the amendments in the names of the noble Lord, Lord Kingsland, and the noble Baroness, Lady Wilcox. Amendment No. 21 seeks to prevent orders conferring powers to legislate entirely. The Government consider that this would create an unacceptable arrangement for this reason: it would impose an unnecessary restriction on the order-making power and reproduce almost precisely one of the barriers to successful regulatory reform under the 2001 Act.
	It has seemed to me during the course of today's debates that there is a fair measure of agreement about the need to regulate, but when it comes down to a particular proposal there is always another argument against it which in itself could create yet another tier of considerations before we finally get round to doing some deregulation. I am anxious to avoid that, but I think this amendment falls into that category.
	Let me give two examples of how the amendment might have held up, or contributed to holding up, beneficial changes. The inability to confer legislative functions by order under the 2001 Act led to a number of sensible proposed orders being dropped or modified. I have already quoted the fire safety regulatory removal order, as it were, and I shall quote it again now. Under that order we could not widen the existing powers to make regulations relating to fire safety to include risk assessment. I was being urged earlier to include risk assessment on the face of the Bill, and I gave good reasons why we could not do that. We could not put a provision regarding risk assessment into that order; and so, if we go back to the 2001 Act principles, as this amendment suggests, that is something that we would not be able to do.
	The second example is that a proposal to givethe Secretary of State powers to make statutory instruments to determine the functions of a new public health agency could not be delivered by a regulatory reform order. In many instances, I am sure that that would be uncontroversial and that Members of your Lordships' House and another place would find it entirely agreeable. But we could not do that under the 2001 Act. There is a good case for being able to do it because, in many instances, it would be an uncontroversial and sensible step forward. I hope that Members of the Committee will give some thought to those examples.
	Amendment No. 22 would prevent orders abolishing bodies or offices established by enactment. I hope that Members of the Committee have had the opportunity to consider points raised concerning the potential of the Bill to deliver mergers of regulators to ease burdens on the regulated sector and to take forward a regulatory environment characterised by the proportionate, risk-based and targeted regulation and inspection process that most of us see as a form of enlightenment. The provision which it is proposed to remove is, in our case, essential to realising those goals; for that reason, I cannot support it.
	Amendment No. 23 introduces what seems to be a less restrictive formulation, but it seeks to provide that an order can contain provision to abolish a body or office only if it also provides that the functions of those bodies are transferred to another person. I have sympathy with that amendment which, in principle, corresponds with the purposes of the provisions in the Bill. However, I also have reservations about the effect of the amendment in practical terms. The abolition and creation of a regulatory body would clearly necessitate the transferral of regulatory functions. However, the very rationale for undertaking such a merger may be not only to transfer existing functions but to modify, create or abolish certain functions to reduce or remove burdens on the regulated. The amendment would mean that there was doubt as to whether such changes could be made to functions. In this way, the amendment could ultimately negate the value of the Bill as a vehicle for delivering beneficial mergers of regulators. It also seems somewhat unnecessary to petition for the restriction or removal of this provision. I hope that Members of the Committee will take assurance that the safeguards in the Bill, as we have discussed them, will always prevent the inappropriate usage of that power.
	The noble Lord, Lord Kingsland, made a couple of important points, in particular about the provision that he said would allow Government to create a new body and then give it legislative functions. There needs to be a provision to allow bodies to be created and have legislative powers conferred on them to allow for the implementation of some mergers of regulators, as recommended in the Hampton review, where functions are to be given to a new body. Completing such mergers successfully may involve conferring a range of functions on new bodies, which may include functions of legislating. Without this provision, it would be necessary to use two orders to complete a number of these mergers—one to create the new body and a subsequent one to confer legislative functions on it. That would be unnecessarily bureaucratic and a poor use of parliamentary time. It is right that Parliament has the opportunity to consider the merits of the proposals of that order at one and the same time.
	The noble Lord, Lord Kingsland, also said he thought there was an inconsistency between Clauses 1 and 2. They have different purposes: Clause 2 is about ensuring that existing regulatory functions are exercised so as to comply with the five principles that have been the thread behind the legislation. Clause 1 is about removing or reducing burdens where a regulatory function is outdated.

Lord Jenkin of Roding: I want two bodies to be named in the correspondence—the Human Tissue Authority and the Human Fertilisation and Embryology Authority. I want those two bodies to be named and to know that they will not be merged under this Bill.